What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder include mood stabilizers (such as lithium and divalproex), antipsychotics (such as risperidone and quetiapine), and adjunctive therapies like omega-3 fatty acids. Known side effects of these treatments can vary: lithium may cause tremor, increased thirst, diarrhea, and subclinical hypothyroidism; divalproex can lead to weight gain, gastrointestinal issues, and liver enzyme changes; antipsychotics like risperidone and quetiapine may result in weight gain, sedation, and metabolic changes. Omega-3 fatty acids are generally well-tolerated but can cause gastrointestinal discomfort in some cases.

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, adjunctive treatments like lamotrigine and asenapine have shown efficacy in managing acute manic and mixed episodes.

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. 4) MDMA-assisted psychotherapy, which is being explored for its benefits in PTSD and may have applications in bipolar disorder. These alternatives offer new avenues for patients who may not respond to traditional psychosocial interventions.

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ITAP + SAFE for Bipolar and Substance Use Disorders (ITAP Trial)

N/A

Waitlist Available

Led By Brandon Gaudiano, PhD

Research Sponsored by Butler Hospital

Eligibility Criteria Checklist

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

Must have

Taking at least one mood-stabilizing medication

Diagnosis of a bipolar-spectrum disorder

Must not have

Younger than age 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

This trial tests two different approaches for helping people with both bipolar disorder and substance use problems. One group gets a special support program with therapy and activities, while the other group gets extra safety check-ins. Both groups continue their usual care.

Who is the study for?

This trial is for adults with both bipolar disorder and a substance use disorder who are on mood-stabilizing medication. Participants must be able to speak and read English. It's not suitable for individuals under the age of 18.

What is being tested?

The study tests two programs: ITAP, a specialized psychosocial intervention, versus SAFE, an enhanced safety monitoring program. Both are in addition to routine care after psychiatric hospitalization for those with co-occurring disorders.

What are the potential side effects?

Since this trial involves psychosocial interventions rather than medications, traditional side effects like you'd see with drugs aren't expected. However, participants may experience stress or discomfort discussing personal issues.

Eligibility Criteria

Inclusion Criteria

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

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I am currently taking medication to stabilize my mood.

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I have been diagnosed with a bipolar disorder.

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 ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinician-Administered Rating Scale for Mania (CARS-M)

Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Integrated Treatment Adherence Program (ITAP)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 pharmacological and psychosocial interventions. Mood stabilizers like lithium work by modulating neurotransmitter activity to stabilize mood swings, while antipsychotics target dopamine and serotonin receptors to manage manic and depressive symptoms. Psychosocial interventions, such as cognitive-behavioral therapy (CBT), focus on changing negative thought patterns and behaviors, improving emotional regulation and coping strategies. These treatments are essential for Bipolar Disorder patients as they address both the biological and psychological aspects of the disorder, leading to more comprehensive and effective symptom management.

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor

130 Previous Clinical Trials

16,333 Total Patients Enrolled

4 Trials studying Bipolar Disorder

227 Patients Enrolled for Bipolar Disorder

National Institute of Mental Health (NIMH)NIH

2,869 Previous Clinical Trials

2,777,376 Total Patients Enrolled

146 Trials studying Bipolar Disorder

63,925 Patients Enrolled for Bipolar Disorder

Brandon Gaudiano, PhDPrincipal InvestigatorButler Hospital

7 Previous Clinical Trials

353 Total Patients Enrolled

1 Trials studying Bipolar Disorder

180 Patients Enrolled for Bipolar Disorder

~33 spots leftby Sep 2025

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