Sponsor study identifier
interventional
3
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)Study Completion
August 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 21, 2008
Actual (reported)April 23, 2008
Actual (reported)August 2009
Actual (reported)August 2009
Actual (reported)February 12, 2016
Actual (reported)BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
3 months
Epworth Sleepiness Scale (General Level of Daytime Sleepiness)
3 month
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
the study was terminated early by the study sponsor due to low enrol...
3 participants (actual enrollment reported by the registry).
First Submitted
April 21, 2008
First Posted
April 23, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder
Contact the study team to confirm eligibility.
Primary Completion
August 2009
Actual (reported)Study Completion
August 2009
Actual (reported)Last Updated
November 22, 2017
Results First Posted
February 12, 2016
Record last verified: 2017-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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