Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.

Official Title
-----------------
Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole

Conditions
-----------------
Bipolar Disorder, Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 65 years Body mass index (BMI) >=25; Currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects; Able to give basic informed consent Meets DSM-IV criteria for lifetime bipolar I or II disorder and are presently in sustained remission (CGI BP<3 in the previous 8-week period measured through a complete psychiatric history at screening and patient report.) Epworth Scale Score > 7 Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study Exclusion Criteria: Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations) Not competent to provide informed consent in the opinion of the investigator Ultra-rapid cycling (>4 episodes per month) bipolar I disorder Unstable and severe medical illness that requires immediate and intensive medical attention, When appropriate, the patients can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study Women who are planning to become pregnant, currently pregnant, or breast-feeding; Current substance dependence; however, if a subject only has substance abuse/use, after the first positive drug screen, another drug screen will be repeated. If that drug screen is positive, the subject will be excluded. If the second drug screen is negative, the subject will be considered for the study; Subjects who have previously failed an adequate trial of aripiprazole. Subjects with a suicide attempt in the past 2 years; Subjects with a history of inpatient admission in the past 1 year; Subjects with a history of homicidal ideation; Any subject for whom the PI deems that the potential risks in participating in the study outweigh the potential benefits.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Aripiprazole | Drug: Aripiprazole<br>* All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.<br>* Other names: Abilify;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns), |  | 3 months | 
| Epworth Sleepiness Scale (General Level of Daytime Sleepiness) |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Functioning |  | 3 months | 
| Quality of Life Enjoyment Questionnaire |  | 3 months | 
| Young Mania Rating Scale |  | 3 months | 
| Hamilton Rating Scale for Depression |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar disorder, sedation, overweight, Abilify, medication