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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intramuscular, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, 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, Powder, for solution

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

89 Actively Recruiting

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

Post Traumatic Stress Disorder

256 Actively Recruiting

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

Bipolar Disorder

0 Actively Recruiting

Schizophrenia

34 Actively Recruiting

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

Mental Depression

2 Actively Recruiting

Not Applicable

Delirium

24 Actively Recruiting

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

Unipolar Depression

51 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

47 Actively Recruiting

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

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 Bryn Mawr Hospital in Bryn Mawr, United States.

Doula Support for Breastfeeding

18+
Female
Bryn Mawr, PA

Parents of infants in the neonatal intensive care unit (NICU) face unique barriers to long-term breastfeeding and lactation. The physical and emotional demands of having a critically ill or premature newborn combined with the stress, sleep deprivation, and separation inherent to the NICU environment make it difficult for many mothers to sustain breastfeeding and lactation, even when they want to. At the same time, NICU mothers are at elevated risk for post-traumatic stress disorder (PTSD) and poor health-related quality of life, which can further undermine lactation success and overall maternal wellbeing. PeliCaN Multi-Site Breastfeeding tests whether a trained postpartum doula, working directly in the NICU can improve breastfeeding and lactation outcomes and support maternal mental health through 6 months postpartum. Participants are enrolled during their infant's NICU hospitalization to receive either doula support or standard care, depending on the study site condition at the time of enrollment (control vs. intervention). Mothers in the intervention group will receive lactation education and support, and emotional and informational support from a NICU-informed doula for up to 6 months. Mothers in the usual care group receive standard NICU clinical care, including access to NICU lactation consultants, without study doula support. All participants complete surveys at enrollment and at 6 months postpartum covering infant feeding practices, maternal mental health, and demographic characteristics. The study asks two primary questions: (1) Does NICU-informed postpartum doula support improve breastfeeding and lactation rates at 6 months? (2) Does doula support improve health-related quality of life and reduce post-traumatic stress disorder symptoms at 6 months? A subset of intervention participants, NICU staff, and lactation consultants will also participate in qualitative interviews and brief implementation surveys to assess how well the doula program works in practice across participating sites.

Waitlist Available
Has No Placebo

Bryn Mawr Hospital (+10 Sites)

Heather H Burris, MD, MPH

Image of VA Puget Sound Health Care System Seattle Division, Seattle, WA in Seattle, United States.

Prazosin for Post-Traumatic Stress Disorder

21 - 75
All Sexes
Seattle, WA

KEY INFORMATION: The purpose of this study is to understand how insulin resistance (how your body processes sugar) and PTSD might be related. The goal is to improve the health of Veterans in three ways: 1. Understanding health risks: The investigators want to learn why Veterans with post-traumatic stress disorder (PTSD) are more likely to develop medical problems related to insulin resistance, such as diabetes. 2. Testing effects of a medication: The investigators are testing whether prazosin, a medication that studies have shown may address some PTSD symptoms, can also improve how the body responds to insulin. If it does, this could point to a specific biological pathway that could be targeted for development of new treatments to prevent insulin resistance and diabetes in Veterans with PTSD. 3. Links to depression. The investigators will also look at whether insulin sensitivity affects depression symptoms in people with PTSD. This may inform future research into treatments for PTSD.

Phase 4
Waitlist Available

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Katharine J Liang, MD PhD

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Image of Summit Hyperbarics and Wellness in Boise, United States.

Hyperbaric Oxygen Therapy for Traumatic Brain Injury

18 - 75
All Sexes
Boise, ID

The goal of this study is to examine changes in blood biomarkers following hyperbaric oxygen therapy (HBOT) in military veterans with traumatic brain injury and persistent post-concussive symptoms. The main questions it aims to answer are: 1. Does HBOT produce measurable changes in inflammatory, neurotrophic, and neuronal injury biomarkers from baseline to completion of a 40-session treatment protocol in veterans with TBI and PCS? 2. Does the presence of comorbid PTSD influence biomarker responses to HBOT among veterans with TBI and PCS? Participants will: Complete medical and behavioral health evaluations to determine eligibility. Provide blood samples before treatment and after the final session. Receive 40 HBOT sessions at 2.0 ATA, generally two sessions per day with at least four hours between sessions. Approximately 34 veterans will participate. All participants will receive HBOT; there is no comparison group.

Phase 2
Recruiting

Summit Hyperbarics and Wellness

Steve Wyman, MD

Image of Steven A. Cohen Military Family Clinics at Red Rock, Colorado Springs in Colorado Springs, United States.

Parenting-STAIR Modular for PTSD and Depression

18+
All Sexes
Colorado Springs, CO

The goal of this clinical trial is to learn if a family-based treatment called Parenting-STAIR-Modular (PSTAIR-M) can help military parents recover from trauma, strengthen emotion regulation skills, and improve parent-child relationships. Participants will be trauma-exposed active-duty Service Members (SM) or their spouses who screen positive for PSTD and/or depression, and one identified child (ages 2-10). The main questions it aims to answer are: 1) Does PSTAIR-M reduce parental PTSD and depression symptoms, lower parenting stress, and improve child behavior compared to treatment-as-usual?; and 2) Is PSTAIR-M feasible and acceptable when delivered to military families stationed overseas? Researchers will compare PSTAIR-M to treatment-as-usual (TAU) to see if PSTAIR-M leads to greater improvements in parental PTSD, depression, parenting stress, emotion regulation, child maltreatment risk, and child behavior than usual care. Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded.

Waitlist Available
Has No Placebo

Steven A. Cohen Military Family Clinics at Red Rock, Colorado Springs (+3 Sites)

Kathrine S Sullivan, PhD

Image of University of California San Diego Health in La Jolla, United States.

Sleep Promotion Strategies for Critical Illness

18+
All Sexes
La Jolla, CA

SHANTI-ICU compares the effectiveness of two evidence-based multicomponent ICU sleep promotion bundles on delirium and patient-reported sleep quality in critically ill adults. Bundle A is a non-pharmacologic strategy. Bundle B includes all components of Bundle A plus pharmacist-led pharmacologic strategies. Sixteen intensive care units across eight hospitals implement one of the two bundles as a unit-level change to routine care, using a concurrent multiple-intervention stepped wedge randomized design. The primary outcome is delirium incidence, measured using the Confusion Assessment Method for the ICU (CAM-ICU) as documented during routine clinical care. Secondary outcomes are delirium duration, ICU length of stay, nightly patient-reported sleep quality, and overall patient-reported ICU sleep quality. Patients receive the assigned bundle as part of routine care. The study operates under an IRB-approved waiver of informed consent and waiver of HIPAA authorization; there is no individual enrollment procedure.

Waitlist Available
Has No Placebo

University of California San Diego Health (+6 Sites)

Biren B Kamdar, MD, MBA, MHS

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Image of Dartmouth Health in Lebanon, United States.

ACP Counselor Video Program for Alzheimer's Disease

65+
All Sexes
Lebanon, NH

The goal of this clinical trial is to make sure that the values of older persons aged 65 years or older with Alzheimer's Disease and Related Dementias (ADRD) or increased risk of mortality are known and respected, thereby reducing the burden of intrusive, unwanted medical interventions on their lives. The main aims of the study are: * To assess the impact of our Advance Care Planning (ACP) Counselor Video Program on ACP documentation and receipt of goal-concordant care in a diverse sample of older adults with ADRD or other serious illness * To compare resuscitation preferences, hospice use, healthcare utilization and costs Researchers will randomize participants into two groups. All participants will continue to receive routine care. Participants randomized to the Immediate-Start Intervention group will be offered the ACP Counselor Video Program during both Phase 1 and Phase 2. Participants randomized to the Routine Care/Delayed-Start Intervention group will receive routine care alone during Phase 1 and will be offered the ACP Counselor Video Program beginning in Phase 2. Each phase will last two years. Both groups will have access to the intervention during Phase 2. During the intervention, participants will: * Meet with ACP counselors * Watch ACP videos.

Waitlist Available
Has No Placebo

Dartmouth Health (+1 Sites)

Michael Paasche-Orlow

Image of Medical University of South Carolina in Charleston, United States.

CHW Support for Post-Traumatic Stress Disorder

18+
All Sexes
Charleston, SC

This pilot study will evaluate the feasibility, acceptability, and preliminary effectiveness of the Trauma Resilience and Recovery Program Plus (TRRP+), a Community Health Worker-enhanced intervention designed to improve behavioral health engagement and recovery among adult trauma survivors with unmet social needs. One hundred adult trauma patients admitted to the Medical University of South Carolina (MUSC) Level I Adult Trauma Center who screen positive for risk of posttraumatic stress disorder (PTSD) or depression and report at least one unmet social need will receive TRRP+ services. Participants will complete assessments at baseline, 1 month, and 3 months after enrollment. The study will also examine implementation barriers and facilitators to support future dissemination and scale-up of the intervention.

Waitlist Available
Has No Placebo

Medical University of South Carolina

Theresa Skojec, PhD

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