Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00665444
• Other study ID #: BMS.WPIC.I#0008449
• Status: Terminated
• Phase: N/A
• First received: April 21, 2008
• Last updated: October 19, 2017
• Start date: April 2008
• Est. completion date: August 2009

Study information

• Verified date: October 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 65 years

2. Body mass index (BMI) >=25;

3. Currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects;

4. Able to give basic informed consent

5. 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.)

6. Epworth Scale Score > 7

7. Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study

Exclusion Criteria:

1. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)

2. Not competent to provide informed consent in the opinion of the investigator

3. Ultra-rapid cycling (>4 episodes per month) bipolar I disorder

4. 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

5. Women who are planning to become pregnant, currently pregnant, or breast-feeding;

6. 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;

7. Subjects who have previously failed an adequate trial of aripiprazole.

8. Subjects with a suicide attempt in the past 2 years;

9. Subjects with a history of inpatient admission in the past 1 year;

10. Subjects with a history of homicidal ideation;

11. Any subject for whom the PI deems that the potential risks in participating in the study outweigh the potential benefits.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Aripiprazole
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),		3 months
Primary	Epworth Sleepiness Scale (General Level of Daytime Sleepiness)		3 month
Secondary	Global Assessment of Functioning		3 months
Secondary	Quality of Life Enjoyment Questionnaire		3 months
Secondary	Young Mania Rating Scale		3 months
Secondary	Hamilton Rating Scale for Depression		3 months