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

90 Actively Recruiting

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

Post Traumatic Stress Disorder

228 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

21 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 investigators 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. Participants who decide to join this study, 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, participants will be asked to give two breath and blood samples to look for signs of general inflammation.

Recruiting
Has No Placebo

White River Junction VA Hospital

Bradley Watts

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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
Online Trial

Pavillon Adrien-Pinard (SU)

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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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