At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 141 enrolled
Drug / intervention
olanzapinedrug
Likely dose
Olanzapine 5–20 mg orally daily (flexible dose) for 24 weeksAI-extracted
Key inclusion· 2
- ✓Meet DSM-IV-TR diagnostic criteria for Bipolar Disorder (any current or most recent episode: Manic, Hypomanic, Mixed, or Major Depressive) confirmed by SCID module D
- ✓Age >18 years at baseline visit
Key exclusion· 1
- ✕Current or lifetime DSM-IV-TR Axis I or II diagnosis that could interfere with study evaluation per investigator judgment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase IIIb, Multicenter, Single-Arm Open-Label Study, Supporting the Development and the Validation of the MATHYS Scale (Multidimensional Assessment of THYmic States) in a Population of Bipolar Patients Treated With Olanzapine, Either in-Label (Manic and Mixed Patients) and Off-Label (Hypomanic and Bipolar Depression)
In Brief
A Phase 3 clinical trial evaluating olanzapine for Bipolar Disorder I or II. Completed, enrolled 141 participants across 16 sites.
Detailed Summary
A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder I or II
CountriesFrance
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
First PostedNov 2005
Primary CompletionMay 2008
TodayJul 2026
First PostedNov 29, 2005
Enrollment StartNov 1, 2005
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.6 years ago
Interventions
olanzapinedrug
5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.