What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder include mood stabilizers (e.g., lithium, lamotrigine), second-generation antipsychotics (e.g., risperidone, quetiapine), and adjunctive therapies like omega-3 fatty acids. Known side effects of mood stabilizers can include tremor, increased thirst, diarrhea, and subclinical hypothyroidism. Second-generation antipsychotics may cause weight gain, metabolic syndrome, and extrapyramidal symptoms. Omega-3 fatty acids are generally well-tolerated but can cause gastrointestinal discomfort. Electroconvulsive therapy (ECT) can lead to memory impairment and headaches, while transcranial magnetic stimulation (TMS) may cause scalp discomfort and, rarely, seizures.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Bipolar Disorder, including mood stabilizers like lithium and valproate, and second-generation antipsychotics such as risperidone, quetiapine, and olanzapine. These medications are often used in combination with psychosocial interventions, including cognitive-behavioral therapy (CBT) and other behavioral strategies, to manage symptoms and improve patient outcomes. Additionally, drugs like lamotrigine and asenapine have been approved for specific phases of bipolar treatment, providing a broad range of options for comprehensive management.

What other types of research exist?

Promising novel alternatives to specialized psychosocial intervention programs for bipolar disorder patients include: 1) Electroconvulsive Therapy (ECT), which has shown efficacy in treatment-resistant bipolar depression; 2) Transcranial Magnetic Stimulation (TMS), particularly maintenance TMS, which has been associated with reduced depressive relapses; 3) Psilocybin-assisted psychotherapy, which has shown potential in treatment-resistant depression; and 4) MDMA-assisted psychotherapy, which is being explored for its benefits in PTSD and may have applications in bipolar disorder.

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ITAP-VA for Bipolar and Substance Use Disorders

N/A

Recruiting

Led By Jane Metrik, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of a mood disorder

Taking at least one psychiatric medication

Must not have

Younger than age 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special program and extra safety checks for Veterans with bipolar disorder and substance use issues. The goal is to help them stick to their treatment plans and ensure their safety after leaving the hospital.

Who is the study for?

This trial is for Veterans with both bipolar and substance use disorders who are on psychiatric medication. Participants must be able to speak and read English and be 18 years or older.

What is being tested?

The study tests two programs: ITAP-VA, a psychosocial intervention, versus SAFE, an enhanced safety monitoring program. Both are in addition to routine care, with participants randomly assigned to either group.

What are the potential side effects?

Since the interventions involve psychosocial treatments rather than medications, typical drug side effects aren't expected. However, discussing sensitive topics might cause temporary distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a mood disorder.

Select...

I am currently taking medication for a mental health condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief Adherence Rating Scale (BARS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Integrated Treatment Adherence Program for Veterans (ITAP-VA)Experimental Treatment1 Intervention

A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.

Group II: Safety Assessment and Follow-up Evaluation (SAFE)Active Control1 Intervention

Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Bipolar Disorder include mood stabilizers (e.g., lithium, divalproex), antipsychotics (e.g., risperidone, quetiapine), and psychosocial interventions. Mood stabilizers work by balancing neurotransmitter levels, reducing the frequency and severity of mood swings. Antipsychotics help manage symptoms of mania and psychosis by blocking dopamine receptors. Psychosocial interventions, such as cognitive-behavioral therapy (CBT), focus on modifying negative thought patterns and behaviors, improving coping strategies, and enhancing medication adherence. These treatments are crucial for Bipolar Disorder patients as they address both the biological and psychological aspects of the disorder, leading to more comprehensive and effective management.