Zyprexa Relprevv

Delirium, Delusional Parasitosis, Schizophrenia + 11 more

Treatment

8 FDA approvals

20 Active Studies for Zyprexa Relprevv

What is Zyprexa Relprevv

Olanzapine

The Generic name of this drug

Treatment Summary

Olanzapine is an antipsychotic medication that belongs to a class of drugs called atypical antipsychotics. It was approved for use in the United States in 1996 and is known to be effective in treating mental illnesses with fewer side effects and drug interactions compared to other antipsychotics. Olanzapine is very similar to the drug clozapine, with two additional methyl groups and no chloride content.

Zyprexa

is the brand name

image of different drug pills on a surface

Zyprexa Relprevv Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Zyprexa

Olanzapine

1996

546

Approved as Treatment by the FDA

Olanzapine, otherwise known as Zyprexa, is approved by the FDA for 8 uses which include Mental Depression and Bipolar Disorder .

Mental Depression

Used to treat Acute Depressive Episode in combination with Fluoxetine

Bipolar Disorder

Used to treat Bipolar 1 Disorder in combination with Fluoxetine

Bipolar Disorder

Used to treat Bipolar Disorder With Manic or Mixed Episodes in combination with Lithium cation

Unipolar Depression

Used to treat Major depressive disorder, recurrent episode in combination with Fluoxetine

Bipolar Disorder With Manic or Mixed Episodes

Used to treat Bipolar Disorder With Manic or Mixed Episodes in combination with Lithium cation

Bipolar 1 Disorder

Used to treat Bipolar 1 Disorder in combination with Fluoxetine

Acute Depressive Episode

Used to treat Acute Depressive Episode in combination with Fluoxetine

Major depressive disorder, recurrent episode

Used to treat Major depressive disorder, recurrent episode in combination with Fluoxetine

Effectiveness

How Zyprexa Relprevv Affects Patients

Olanzapine works by targeting two different receptors in the brain - the dopamine D2 receptor and the serotonin 5HT2A receptor. This action has been found to be effective in reducing symptoms of schizophrenia, bipolar disorder in adults and acute episodes of bipolar disorder in adolescents. It has also been demonstrated to be successful in reducing chemotherapy-induced nausea and vomiting. Studies have shown that olanzapine can produce a complete response in 84% of individuals and control nausea and vomiting for over 80%.

How Zyprexa Relprevv works in the body

Olanzapine works by blocking various receptors in the brain, including dopamine and serotonin receptors. Blocking dopamine receptors in the mesolimbic pathway is key to its activity. Olanzapine binds to these receptors and makes it harder for dopamine to activate them. It also affects serotonin 5HT2A receptors in the frontal cortex, which helps reduce unwanted side effects.

When to interrupt dosage

The suggested dosage of Zyprexa Relprevv is contingent upon the diagnosed affliction, including Schizophrenia, Bipolar Disorder and Delirium. The amount of dosage likewise varies, in line with the technique of delivery (e.g. Kit - Intramuscular or Tablet, film coated - Oral) as noted in the below table.

Condition

Dosage

Administration

Delirium

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Schizophrenia

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Schizophrenia

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Bipolar Disorder

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Post Traumatic Stress Disorder

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Tourette Syndrome

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Mental Depression

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Acute Agitation

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Unipolar Depression

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Acute Coryza

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Delusional Parasitosis

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Bipolar Disorder

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Alzheimer's Disease

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Bipolar Disorder

2.5 mg, , 5.0 mg, 20.0 mg, 15.0 mg, 10.0 mg, 10.0 mg/mL, 7.5 mg, 3.0 mg, 6.0 mg, 12.0 mg, 210.0 mg, 300.0 mg, 405.0 mg, 405.0 mg/mL, 300.0 mg/mL, 210.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, powder, for solution - Intramuscular, Intramuscular, Injection, powder, for solution, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, orally disintegrating, Powder, for solution, Powder, for solution - Intramuscular, Tablet, coated, Tablet, coated - Oral, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Kit, Kit - Intramuscular, Tablet, orally disintegrating - Oral, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular

Warnings

There are 20 known major drug interactions with Zyprexa Relprevv.

Common Zyprexa Relprevv Drug Interactions

Drug Name

Risk Level

Description

Acenocoumarol

Major

The metabolism of Acenocoumarol can be decreased when combined with Olanzapine.

Acepromazine

Major

Olanzapine may increase the orthostatic hypotensive, hypotensive, and antihypertensive activities of Acepromazine.

Aclidinium

Major

The risk or severity of adverse effects can be increased when Olanzapine is combined with Aclidinium.

Alfuzosin

Major

Olanzapine may increase the hypotensive activities of Alfuzosin.

Amisulpride

Major

Olanzapine may increase the antipsychotic activities of Amisulpride.

Zyprexa Relprevv Toxicity & Overdose Risk

Taking too much olanzapine can cause drowsiness, dilated pupils, slow breathing, low blood pressure, muscle stiffness, and dry mouth. Clinical trials have reported the maximum dose of olanzapine to be 300mg, which can cause slurred speech and drowsiness. However, reports of more serious side effects after taking higher doses of olanzapine, such as agitation, difficulty speaking, fast heartbeat, muscle stiffness, and loss of consciousness, have been noted. In one case, a person died after taking 450mg of olanzapine. Treatment for an overdose may include providing oxygen

Zyprexa Relprevv Novel Uses: Which Conditions Have a Clinical Trial Featuring Zyprexa Relprevv?

578 active clinical trials are exploring the potential of Zyprexa Relprevv in the management of Schizophrenia, Post Traumatic Stress Disorder and Delusional Parasitosis.

Condition

Clinical Trials

Trial Phases

Schizophrenia

94 Actively Recruiting

Phase 3, Not Applicable, Early Phase 1, Phase 4, Phase 1, Phase 2

Post Traumatic Stress Disorder

235 Actively Recruiting

Early Phase 1, Not Applicable, Phase 3, Phase 2, Phase 4, Phase 1

Bipolar Disorder

0 Actively Recruiting

Schizophrenia

30 Actively Recruiting

Early Phase 1, Not Applicable, Phase 4

Mental Depression

2 Actively Recruiting

Phase 2, Not Applicable

Delirium

22 Actively Recruiting

Phase 2, Phase 3, Not Applicable, Phase 4, Early Phase 1

Unipolar Depression

46 Actively Recruiting

Not Applicable, Early Phase 1, Phase 3, Phase 2, Phase 1

Bipolar Disorder

0 Actively Recruiting

Bipolar Disorder

0 Actively Recruiting

Delusional Parasitosis

0 Actively Recruiting

Alzheimer's Disease

37 Actively Recruiting

Phase 4, Phase 2, Phase 3, Not Applicable, Phase 1

Acute Coryza

0 Actively Recruiting

Acute Agitation

0 Actively Recruiting

Tourette Syndrome

0 Actively Recruiting

Patient Q&A Section about zyprexa relprevv

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How long does Zyprexa IM injection last?

"Olanzapine extended-release injection is typically given once every 2 to 4 weeks. Olanzapine extended-release injection may help manage your symptoms but will not cure your condition."

Answered by AI

Is Zyprexa Relprevv still available?

"Because of the potential risks, ZYPREXA RELPREVV is only available through a restricted distribution program called the ZYPREXA RELPREVV Patient Care Program. This program requires enrollment of the prescriber, healthcare facility, patient, and pharmacy. [see Dosage and Administration (2.1), Warnings and Precautions (5.1, 5.2), Overdosage (10.2), and ..."

Answered by AI

How do you administer Zyprexa Relprevv?

"Zyprexa Relprevv should be administered by a healthcare professional every 2 to 4 weeks by deep intramuscular gluteal injection using a 19-gauge, 1.5-inch needle. Following insertion of the needle into the muscle, the healthcare professional should aspirate for several seconds to ensure that no blood is drawn into the syringe."

Answered by AI

How long does Zyprexa Relprevv last?

"Olanzapine as a pamoate monohydrate is a long-lasting injectable or depot form of olanzapine that provides another option for maintaining treatment of schizophrenia. It is administered by deep intramuscular gluteal injection only, every 2 weeks or every 4 weeks."

Answered by AI

Clinical Trials for Zyprexa Relprevv

Image of Stanford University School of Medicine in Stanford, United States.

BEAR Program for Suicidal Thoughts

18 - 75
Female
Stanford, CA

The current study aims to test the feasibility of a new form of group therapy for women who have a history of interpersonal trauma and current suicidal ideation. The Building Empowerment and Resilience (BEAR) Therapeutic group has been adapted for women who have experienced trauma and have current suicidal ideation. It incorporates psychological skills, psychoeducation about trauma and gender-based violence, and physical self-defense training, all within a therapeutic process. It will be implemented with women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect) and experience various mental health difficulties, including suicidal ideation. We aim to assess the feasibility to recruit and implement the BEAR group. Our ultimate aim is to assess whether the program can effect self-efficacy and suicidal ideation.

Waitlist Available
Has No Placebo

Stanford University School of Medicine

Jennifer Keller, PhD

Image of White River Junction VA Hospital in White River Junction, United States.

Transcranial Magnetic Stimulation for PTSD

19 - 70
All Sexes
White River Junction, VT

With this research we hope to begin to understand how rTMS can improve posttraumatic stress disorder (PTSD) symptoms. TMS improves PTSD through two interrelated mechanisms: change in brain limbic system function and change in systemic inflammatory activation. If you decide to join this study, you will receive ten rTMS treatments. All participants will undergo a 40-minute rTMS procedure with a member of the study team 10 times over 2-4 weeks. Participants will undergo fMRI scans of the head in order to help researchers better understand potential effects of rTMS on brain activity. In addition, you will be asked to give two breath and blood samples to look for general signs of inflammation.

Recruiting
Has No Placebo

White River Junction VA Hospital

Bradley Watts

Image of University of California at San Diego (UCSD) in San Diego, United States.

Neuronavigated aiTBS for Depression

18 - 65
All Sexes
San Diego, CA

The purpose of this study is to confirm the efficacy of two recently introduced repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation - in treatment-resistant depression (TRD). Using a three-arm design (neuronavigated aiTBS, non-neuronavigated aiTBS, and sham), this randomized controlled trial (RCT) is the first to specifically investigate the incremental benefit of neuronavigation within an accelerated stimulation protocol, as well as the first confirmatory RCT comparing the efficacy of each of these active treatments vs. sham, overcoming previous generalizability issues and being conducted in an independent, multicenter US TRD sample.

Waitlist Available
New This Month

University of California at San Diego (UCSD) (+2 Sites)

Have you considered Zyprexa Relprevv clinical trials?

We made a collection of clinical trials featuring Zyprexa Relprevv, we think they might fit your search criteria.
Go to Trials
Image of Pavillon Adrien-Pinard (SU) in Montreal, Canada.

Cognitive Remediation for PTSD

18 - 45
All Sexes
Montreal, Canada

The goal of this clinical trial is to evaluate whether computer-based brain training can help adults with post-traumatic stress disorder (PTSD). Individuals with PTSD often experience difficulties with memory, attention, concentration, and problem-solving, which can significantly affect their daily lives, work performance, and overall quality of life. These cognitive challenges can hinder trauma recovery and reduce the effectiveness of standard PTSD treatments. The main questions this study seeks to address are: Does specialized brain training improve PTSD symptoms compared to regular computer games? Does brain training enhance cognitive functions such as memory, attention, processing speed, and executive functioning? Does brain training improve quality of life and daily functioning? Do participants' self-efficacy and perceived social support influence treatment outcomes? Researchers will compare two approaches: a specialized cognitive training program (HAPPYneuron Pro) with strategy teachings and quality-of-life discussions, versus engaging computer games with quality-of-life discussions, to determine which is more effective for people with PTSD. Study Design Participants will be randomly assigned to one of two groups for an 8-week program: Cognitive remediation training group: Complete computerized cognitive exercises and strategy teachings specifically designed to strengthen memory, attention, and executive functions, combined with quality-of-life discussions. Control group: Complete engaging computer games combined with quality-of-life discussions. Schedule Both groups will follow the same schedule: One online session per week, in small and consistent groups of 6 participants. Each 60-minute session consists of 30 minutes of computer activities followed by 45 minutes of group discussion. One at-home individual homework exercise per week (30 minutes at home). Total time commitment: 1h45 per week for 8 weeks. Assessments All participants will complete three comprehensive assessment sessions: before treatment, immediately after the 8-week program, and 3 months later. Assessments include neuropsychological testing and questionnaires on PTSD symptoms, depression, anxiety, quality of life, satisfaction with life, social support, cognitive failures, and self-efficacy. Significance This research evaluates a new, accessible and remotely deliverable approach for PTSD treatment. Current evidence-based treatments often do not directly target the cognitive impairments experienced by many individuals with PTSD. Compensation Participants will receive $35 for each completed assessment (maximum $105). Control group participants will gain access to the cognitive remediation training program after completing their participation.

Recruiting
New This Month

Pavillon Adrien-Pinard (SU)

Image of Walter Reed National Military Medical Center/Uniformed Services University in Bethesda, United States.

NightWare Smartwatch for Insomnia

18 - 62
All Sexes
Bethesda, MD

The INSIGHT study is a multi-site clinical research program designed to examine how insomnia and symptoms of sympathetic hyperactivity impair sleep, cognition, and physiological restoration in warfighters, and to evaluate whether a wearable therapeutic device can improve these outcomes. Warfighters with a history of traumatic brain injury, post-traumatic stress disorder, or chronic operational stress commonly report disrupted sleep accompanied by manifestations of nocturnal sympathetic activation such as diaphoresis, palpitations, hyperarousal, and nightmares. These symptoms erode sleep quality, reduce cognitive performance, and undermine psychological resilience and operational readiness. Insomnia is two to three times more common in military populations than in civilians, and both TBI and PTSD independently elevate the risk for dysregulated autonomic tone. Excessive sympathetic activity during REM sleep disrupts the normally quiescent locus coeruleus state required for adaptive emotional processing and may contribute to the genesis of nightmares. Excessive sympathetic tone may also interfere with deep NREM-dependent glymphatic clearance, a recently discovered mechanism that supports cognitive restoration and metabolic waste removal. Yet, no study has comprehensively linked these physiological processes in warfighters or evaluated whether wearable-derived autonomic measures can meaningfully stratify insomnia phenotypes. The INSIGHT protocol addresses this gap through a two-phase design integrating multimodal biomarker collection, wearable technology validation, advanced imaging, and a randomized controlled intervention. Phase 1 enrolls 250 participants (50 healthy controls and 200 poor sleepers with or without PTSD and TBI) who undergo structured screening, cognitive testing, and detailed baseline assessments before completing a 2-week at-home data collection period. During this period, participants wear a suite of devices, including EEG headbands, ECG patches, PPG-based sensors, accelerometry rings, blood pressure devices, temperature sensors, and smartwatches, to capture autonomic activity, sleep architecture, cardiovascular and respiratory variability, movement, sudomotor activity, and circadian body temperature patterns. Ecological momentary assessments administered three times daily track fluctuations in sleep quality, mood, PTSD symptoms, and daytime functioning, while urine samples collected on the final three days allow for biochemical analysis of hormonal and sympathetic biomarkers. After the at-home period, all participants complete an overnight in-lab polysomnogram combined with fNIRS to measure sleep stages, autonomic dynamics, cerebral hemodynamics, and glymphatic signatures. A subset of participants also completes an optional overnight MRI with simultaneous EEG following controlled sleep deprivation, enabling state-of-the-art imaging of human glymphatic activity using the MAGNUS MRI platform. This optional visit provides unprecedented insight into how TBI, PTSD, and insomnia alter the physiology of sleep-dependent brain fluid dynamics. In Phase 2, all poor sleepers enter a double-blind, sham-controlled, 30-day randomized trial testing the therapeutic potential of the NightWare smartwatch. NightWare detects sympathetic surges during sleep through heart rate elevations and movement patterns and delivers brief haptic vibrations aimed at interrupting escalating autonomic arousal. Although originally cleared for nightmare treatment, its mechanism is well suited for SNH-related insomnia more broadly. Participants use the device daily while continuing EMA surveys, wearable monitoring, and cognitive assessments, generating rich physiological and behavioral data throughout the intervention. The primary goal is to determine whether reducing nocturnal sympathetic spikes leads to measurable improvements in sleep quality, autonomic stability, daytime functioning, and symptom burden. In parallel, Phase 2 data enable development of the Multi-Organ Autonomic Index of Sleep, an integrated biomarker model that combines neurological, cardiovascular, respiratory, and dermal signals to predict treatment response and classify insomnia subtypes. The INSIGHT study will produce the most comprehensive dataset to date linking autonomic physiology, glymphatic function, sleep architecture, wearable-derived biomarkers, cognition, and clinical outcomes in warfighters. By identifying physiological signatures of sympathetic hyperarousal and determining whether a non-pharmacological wearable intervention can meaningfully improve sleep, INSIGHT directly supports Department of Defense priorities to enhance readiness, resilience, and long-term neurological health in service members. Wearable tools capable of monitoring and improving sleep outside the laboratory have the potential to transform both clinical care and operational performance, offering scalable and accessible approaches to restoring sleep and optimizing recovery.

Waitlist Available
Paid Trial

Walter Reed National Military Medical Center/Uniformed Services University (+1 Sites)

Have you considered Zyprexa Relprevv clinical trials?

We made a collection of clinical trials featuring Zyprexa Relprevv, we think they might fit your search criteria.
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Image of Emory Brain Health Center in Atlanta, United States.

MDMA-Assisted Therapy for PTSD

21 - 70
All Sexes
Atlanta, GA

The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants. The main questions it aims to answer are: * Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo? * Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo? * Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes? Participants will: * Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks * Be administered either 100 mg of MDMA or a placebo at Visit 2 * Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up

Phase 2
Waitlist Available

Emory Brain Health Center

Jessica Maples-Keller, PhD

Image of University of Colorado Anschutz Medical Campus in Aurora, United States.

Senseye Diagnostic Tool for Post-Traumatic Stress Disorder

18+
All Sexes
Aurora, CO

The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to PTSD. The Senseye DT is software as a medical device (SaMD) and is an iPhone app that administers a series of simple tasks on the phone while recording video during the tasks through the front-facing camera. The videos are analyzed by a a Machine Learning (ML) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the ML algorithm, then test it for accuracy. The main questions this study aims to answer are: 1. How accurate is the Senseye DT in detecting PTSD compared to structured clinical interviews, the current clinical standard for diagnostic testing? 2. How accurately does the Senseye DT predict PTSD severity? 3. How fast is the Senseye DT to use compared to structured clinical interviews? Participants will attend a virtual screening visit via video call to determine eligibility and consent to participate. Once enrolled, participants will attend 2 or 3 additional study visits: * Visit 1: A virtual visit where standard mental health assessments will be given by clinical raters trained in mental health and administering these structured clinical interviews. These assessments include the Structured Interview Guide for the Montgomery-Asburg Depression Rating Scale (SIGMA), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), and the MINI International Neurodiagnostic Interview. The Clinician-Administered PTSD Scale for DSM-5 Revised Version (CAPS-5-R) may also be conducted, if randomly selected. * Visit 2: A visit to use the Senseye DT. For participants near one of the study's physical site locations, this visit will be done in person at the site. For all others, this visit will be conducted virtually. * Visit 3: For participants not randomly selected to have the CAPS-5-R administered at Visit 1, a third and final visit will be scheduled for this assessment. This visit will be conducted virtually. The total expected participation time for enrolled participants is 6-7 hours over the course of 2-3 weeks.

Phase 3
Waitlist Available

University of Colorado Anschutz Medical Campus (+3 Sites)

Senseye, Inc.

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Deaf CBT-TS for Suicide Risk

18+
All Sexes
Rochester, NY

The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are: * Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors? * Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use? * Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress? * Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors. Participants will: * Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment. * Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months * Complete two follow-up assessments in 2 and 4 months.

Waitlist Available
Has No Placebo

University of Rochester Medical Center

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