Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00665444
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 3
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder; Metabolic Syndrome	Drug: Aripiprazole	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Experimental: A Aripiprazole

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.; Other Names: Abilify

Outcome Measures

Primary Outcome Measures

1. BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns), [3 months]

2. Epworth Sleepiness Scale (General Level of Daytime Sleepiness) [3 month]

Secondary Outcome Measures

1. Global Assessment of Functioning [3 months]

2. Quality of Life Enjoyment Questionnaire [3 months]

3. Young Mania Rating Scale [3 months]

4. Hamilton Rating Scale for Depression [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Holly Swartz, Professor of Psychiatry, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00665444
• Other Study ID Numbers: BMS.WPIC.I#0008449
• First Posted: Apr 23, 2008
• Last Update Posted: Nov 22, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Holly Swartz, Professor of Psychiatry, University of Pittsburgh: bipolar disorder; sedation; overweight; Abilify; medication
• Additional relevant MeSH terms: Metabolic Syndrome; Disease; Bipolar Disorder; Aripiprazole

Study Results

Participant Flow

Arm/Group Title	Aripiprazole
Arm/Group Description	Aripiprazole 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.
Period Title: Overall Study
STARTED	3
COMPLETED	1
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Aripiprazole
Arm/Group Description	Aripiprazole 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.
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.7 (4.7)
Sex: Female, Male (Count of Participants)
Female	2 66.7%
Male	1 33.3%
Region of Enrollment (participants) [Number]
United States	3 100%

Outcome Measures

1. Primary Outcome

Title	BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.

Arm/Group Title	Aripiprazole
Arm/Group Description	Aripiprazole 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.
Measure Participants	0

2. Primary Outcome

Title	Epworth Sleepiness Scale (General Level of Daytime Sleepiness)
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.

Arm/Group Title	Aripiprazole
Arm/Group Description	Aripiprazole 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.
Measure Participants	0

3. Secondary Outcome

Title	Global Assessment of Functioning
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Study was terminated early and data were not collected for this outcome.

Arm/Group Title	Aripiprazole
Arm/Group Description	Aripiprazole 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.
Measure Participants	0

4. Secondary Outcome

Title	Quality of Life Enjoyment Questionnaire
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Study was terminated early and data were not collected for this outcome.

Arm/Group Title	Aripiprazole
Arm/Group Description	Aripiprazole 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.
Measure Participants	0

5. Secondary Outcome

Title	Young Mania Rating Scale
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Study was terminated early and data were not collected for this outcome.

Arm/Group Title	Aripiprazole
Arm/Group Description	Aripiprazole 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.
Measure Participants	0

6. Secondary Outcome

Title	Hamilton Rating Scale for Depression
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Study was terminated early and data were not collected for this outcome.

Arm/Group Title	Aripiprazole
Arm/Group Description	Aripiprazole 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.
Measure Participants	0

Adverse Events

Arm/Group Title	Aripiprazole
Arm/Group Description	Aripiprazole 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.
All Cause Mortality
	Aripiprazole
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Aripiprazole
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Aripiprazole
	Affected / at Risk (%)	# Events
Total	0/3 (0%)

Limitations/Caveats

the study was terminated early by the study sponsor due to low enrol...

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.