NCT00592358|TerminatedPhase 4Results
Study Stopped
Slow enrollment.
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Slow enrollment.
Open-Label Study of Invega for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder
Sponsor study identifier
interventional
17
1 country
1
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. Specific hypotheses are as follows: Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV Bipolar I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment. Hypothesis 2: Invega -associated improvement in bipolar disorder symptomatology in children and adolescents will translate into improved functional capacities (neuropsychological, social, and occupational), as well as an increased quality of life throughout treatment. Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop out rate and absence of major side effects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 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.
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 28, 2007
Actual (reported)January 14, 2008
Actual (reported)December 2009
Actual (reported)December 2009
Actual (reported)July 4, 2012
Actual (reported)Change in Symptoms Measured by Young Mania Rating Scale (YMRS)
The YMRS is an 11-item instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. Four items are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven itemsare graded on a 0 to 4 scale. The maximum possible total score is 60 (worse outcome, severe symptoms), and the minimum possible total score is 0 (no symptoms).
Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)
Change in Symptoms Measured by DSM-IV Mania Symptoms Checklist
Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)
tablet, 3mgQAM - 6mgQAM, taken daily for 8 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Cambridge, Massachusetts, 02138, United States
Janet Wozniak, MD
Massachusetts General Hospital
17 participants (actual enrollment reported by the registry).
First Submitted
December 28, 2007
First Posted
January 14, 2008
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
July 4, 2012
Results First Posted
July 4, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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