Health Condition 1: null- Bipolar 1 disorder recurrence
Conditions
Interventions
Intervention1: Drug: Asenapine sublingual tablets(5 to 10 mg ) & Asenapine-matched placebo sublingual tablets BID: Dose-5 & 10mg
Route-Sublingual
Frequency-twice a day
All study participants will firs
Sponsors
Forest Research Institute Inc a wholly owned subsidiary of Forest Laboratories LLC
PAREXEL International Clinical Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception.2.Each participant must be willing and able to provide written informed consent.3.Each participant must have an identified external contact person or an identified responsible person.4.Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TRTM] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview [MINI]) at Screening.5. Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode.Double-Blind Treatment Period6. Each subject must have completed a minimum of 12 weeks and up to 16 weeks of the Open-LabelTreatment Period;7. Each subject must have met one of the following stabilization criteria:a. A Y-MRS and MADRS scores of less than or equal to 12 at either the last 5 consecutive visits of the Open-LabelTreatment Period (ie, visits at Weeks 4, 6, 8, 10, and 12 or visits at Weeks 6, 8, 10, 12, and 14 orWeeks 8, 10, 12, 14, and 16); orb. A Y-MRS and MADRS scores of less than or equal to12 at 5 out of 6 consecutive visits, with only one excursion eventprior to the last visit in the series (the subject met the Y-MRS and MADRS scores at Weeks 6 and 16,and also 3 out of 4 times at Weeks 8, 10, 12, or 14;Note: Subjects must be on asenapine as a monotherapy (ie, previous psychotropic medications already discontinued) for 4 weeks before a stabilization period of 8 weeks can be evaluated. During the 8 week stabilization period an excursion event of Y-MRS and/or MADRS score of less than 16 at a single visit is permitted; excursions of more than or equal to 16 require the subject to be discontinued from the trial.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled, unstable clinically significant medical condition.2. Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at Screening.3. Current primary Axis I disorder other than bipolar 1 disorder.4. Meets the current DSM-IV-TRTM criteria forsubstance abuse or dependence (excluding nicotine).5. Imminent risk of self-harm or harm to others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time (in days) to recurrence of any mood event during the double-blind treatment periodTimepoint: The time (in days) to recurrence of any mood event during the double-blind treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| For Double-Blind Treatment Period( by visit)â?¢Change from double-blind baseline in Y-MRS total scores, MADRS total scores, total PANSS scores and subscale (positive, negative, general psychopathology) scores,PANSS Marder factor (positive, negative, disorganized thought, hostility/excitement, and anxiety/depression symptom) scoresâ?¢Change from double-blind baseline on CGI-BP severity scoresIn AdditionTimepoint: By Visit;For Open-Label Treatment Period: (by visit) â?¢ Change from Baseline in Y-MRS total scoreâ?¢ Change from Baseline on MADRS total scores â?¢ Change from Baseline on total PANSS scores and subscale (positive, negative, general psychopathology)scores â?¢ Change from Baseline on PANSS Marder factor (positive, negative, disorganized thought,hostility/excitement, and anxiety/depression symptom) scoresâ?¢ Change from Baseline on each CGI-BP severity scoreTimepoint: By visit;For Randomized Subjects Only(by visit): â?¢ Change from open-label baseline in Y-MRS total score â?¢ Change from open-label baseline in MADRS total scoreTimepoint: By Visit | — |
Countries
Bulgaria, Croatia, India, Philippines, Romania, Russian Federation, Serbia, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Annappa Kamath
PAREXEL International Clinical Research Private Limited
Outcome results
None listed