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Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00665444
Recruitment Status : Terminated (The study was terminated by the sponser due to low study enrollment.)
First Posted : April 23, 2008
Results First Posted : February 12, 2016
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Holly Swartz, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Metabolic Syndrome
Intervention Drug: Aripiprazole
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole
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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
Reason Not Completed
Physician Decision             1
Study Terminated by Study Sponsor             1
Arm/Group Title Aripiprazole
Hide 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 Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
56.7  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Epworth Sleepiness Scale (General Level of Daytime Sleepiness)
Hide Description [Not Specified]
Time Frame 3 month
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Global Assessment of Functioning
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early and data were not collected for this outcome.
Arm/Group Title Aripiprazole
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Quality of Life Enjoyment Questionnaire
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early and data were not collected for this outcome.
Arm/Group Title Aripiprazole
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Young Mania Rating Scale
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early and data were not collected for this outcome.
Arm/Group Title Aripiprazole
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Hamilton Rating Scale for Depression
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early and data were not collected for this outcome.
Arm/Group Title Aripiprazole
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aripiprazole
Affected / at Risk (%)
Total   0/3 (0.00%) 
the study was terminated early by the study sponsor due to low enrol...
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.
Results Point of Contact
Name/Title: Holly Swartz, MD
Organization: University of Pittsburgh
Phone: 412-246-5588
Responsible Party: Holly Swartz, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00665444     History of Changes
Other Study ID Numbers: BMS.WPIC.I#0008449
First Submitted: April 21, 2008
First Posted: April 23, 2008
Results First Submitted: January 14, 2016
Results First Posted: February 12, 2016
Last Update Posted: November 22, 2017