Zyprexa Zydis

Delirium, Delusional Parasitosis, Schizophrenia + 11 more

Treatment

8 FDA approvals

20 Active Studies for Zyprexa Zydis

What is Zyprexa Zydis

Olanzapine

The Generic name of this drug

Treatment Summary

Olanzapine is an atypical antipsychotic medication used to treat mental health conditions. It was introduced in the 1990s and is known for its effectiveness, reduced risk of side effects and low chance of drug-drug interactions. Olanzapine is similar to clozapine but has two additional methyl groups and no chloride moiety. It was approved by the FDA and released in the US in 1996.

Zyprexa

is the brand name

image of different drug pills on a surface

Zyprexa Zydis 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 Zydis Affects Patients

Olanzapine works by targeting the dopamine D2 receptor and the serotonin 5HT2A receptor in the body. This helps to decrease hallucinations, delusions, disorganized speech, disorganized thought, and disorganized behavior, as well as improve feelings of sadness, lack of energy, lack of interest in activities, difficulty making decisions, and poor attention. Olanzapine has been shown to be effective in treating schizophrenia and bipolar disorder in adults and reducing manic or mixed episodes in adolescents. It has also been studied for its ability to reduce nausea and vomiting caused by chemotherapy, with studies showing that it can help control these symptoms in over 80

How Zyprexa Zydis works in the body

Olanzapine works by blocking receptors in the brain, including receptors for dopamine and serotonin. This blocking prevents dopamine from having an effect on the post-synaptic receptor. Olanzapine also blocks serotonin receptors in the frontal cortex, which helps reduce side effects.

When to interrupt dosage

The advised dosage of Zyprexa Zydis is contingent upon the recognized condition, such as Schizophrenia, Bipolar Disorder and Delirium. The measure of dosage fluctuates as per the method of administration (e.g. Kit - Intramuscular or Tablet, film coated - Oral) detailed in the table beneath.

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 Zydis.

Common Zyprexa Zydis 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 Zydis Toxicity & Overdose Risk

Taking too much olanzapine can cause drowsiness, enlarged pupils, slow or shallow breathing, low blood pressure, muscle stiffness, dry mouth, and confusion. In more severe cases, people may experience agitation, slurred speech, fast heartbeat, and reduced consciousness. In rare cases, taking too much olanzapine can even lead to death. If someone has overdosed on olanzapine, it is important to ensure they are getting enough oxygen and to give them activated charcoal with a laxative. Animal studies have linked olanzapine to an increased risk of liver tumors, mammary gland tumors

image of a doctor in a lab doing drug, clinical research

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

At present, 578 active clinical trials are evaluating the potential of Zyprexa Zydis to alleviate 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

Zyprexa Zydis Reviews: What are patients saying about Zyprexa Zydis?

5

Patient Review

2/18/2012

Zyprexa Zydis for Additional Medications to Treat Depression

Zydis has really helped me. I've experienced an increase in appetite and weight gain, but it's worth it for the relief it provides.

5

Patient Review

7/19/2009

Zyprexa Zydis for Additional Medications to Treat Depression

I found this medication to be really great. I had no issues with weight gain, depression, anxiety, or concentration at a dose of 10 mg at night.

5

Patient Review

1/10/2009

Zyprexa Zydis for Mental Disorder with Loss of Normal Personality & Reality

I am so pleased with this medication. I only wish I had started taking it sooner.

5

Patient Review

12/2/2008

Zyprexa Zydis for Bipolar Disorder in Remission

If you've gained weight, get active and go to the gym or something! Zyprexa has always worked for me and I haven't had any issues for years now.

3.7

Patient Review

10/2/2009

Zyprexa Zydis for Mental Disorder with Loss of Normal Personality & Reality

I am a 240 pound, 5'5" male with high cholesterol and triglycerides.

3.3

Patient Review

4/13/2009

Zyprexa Zydis for Schizophrenia

Worked great at first, but then the effects petered out after a few months. I still experienced some side effects even after it stopped being effective which were mostly increased appetite and fatigue. Your experience may be different, but mine was not good.

3

Patient Review

11/6/2007

Zyprexa Zydis for Bipolar I Disorder with Most Recent Episode Mixed

I find that if I don't take this medication, I feel more anxious; however, it doesn't seem to do much else. The downside is that I've experienced severe weight gain as a result of taking it.

3

Patient Review

4/23/2012

Zyprexa Zydis for Bipolar I Disorder with Most Recent Episode Mixed

This medication was successful in curbing her manic episodes of anxiety and anger. However, once it hit her system she became incredibly depressed and would cry for hours on end. We haven't decided if we will continue using it yet.

3

Patient Review

8/25/2011

Zyprexa Zydis for Schizophrenia

My weight has been more unstable since I began taking this medication.

2.7

Patient Review

12/28/2007

Zyprexa Zydis for Additional Medications to Treat Depression

I've found that my symptoms have actually gotten worse since starting this medication, and I've also gained weight.

1

Patient Review

11/10/2009

Zyprexa Zydis for Manic-Depression

I haven't tried it yet.

1

Patient Review

5/25/2014

Zyprexa Zydis for Bipolar I Disorder with Most Recent Episode Mixed

I gained a ton of weight in just three weeks from using this. Please, look for something else!
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about zyprexa zydis

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

Is Zyprexa and Zyprexa Zydis the same thing?

"Zyprexa Zydis wafers are just as effective as Zyprexa coated tablets, with a similar rate and extent of absorption. Zyprexa Zydis wafers have the same dosage and frequency of administration as Zyprexa coated tablets. Zyprexa Zydis wafers may be used as an alternative to Zyprexa coated tablets."

Answered by AI

How long does it take for Zyprexa Zydis to dissolve?

"For treating bipolar disorder on a long-term basis, the recommended dose of olanzapine is 5-20 mg per day. The orally disintegrating tablet form of olanzapine is placed in your mouth, where it will dissolve within a few seconds."

Answered by AI

How do you administer Zyprexa Zydis?

"To take ZYPREXA ZYDIS (olanzapine orally disintegrating tablets), open the sachet and peel back the foil on the blister. Do not push the tablet through the foil. Using dry hands, remove the tablet from the blister and place the entire tablet in your mouth."

Answered by AI

What is Zyprexa Zydis used for?

"Olanzapine belongs to a class of drugs called atypical antipsychotics.

Olanzapine is a drug used to treat mental and mood conditions such as schizophrenia and bipolar disorder. It may also be used to treat depression in combination with other medications. Olanzapine belongs to a class of drugs called atypical antipsychotics."

Answered by AI

Clinical Trials for Zyprexa Zydis

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

Have you considered Zyprexa Zydis clinical trials?

We made a collection of clinical trials featuring Zyprexa Zydis, we think they might fit your search criteria.
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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)

Have you considered Zyprexa Zydis clinical trials?

We made a collection of clinical trials featuring Zyprexa Zydis, we think they might fit your search criteria.
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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

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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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