Clinical trial NCT00764478: Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)
Official title: A Phase 3b, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three Week Placebo Controlled Trial Evaluating the Safety and Efficacy of Asenapine in Subjects With Bipolar 1 Disorder Experiencing an Acute Manic or Mixed Episode (Protocol P05691 [Formerly 041044])
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar 1 Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily \[BID\]) or placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. The primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating Scale \[YMRS\]) at Day 21 of the trial.


Eligibility criteria: Inclusion Criteria:

* Each participant must be at least 18 years of age
* 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
* Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
* Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
* Each participant must have discontinued the use of all prohibited psychotropic medications

Exclusion Criteria:

* A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
* A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
* A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).

Primary outcomes:
measure: Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21
timeFrame: Baseline and Day 21
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression - Bipolar Mania - Severity of Illness (CGI-BP-S) Overall Score at Day 21
timeFrame: Baseline and Day 21
measure: Percentage of Participants Who Are Y-MRS Responders at Day 21
timeFrame: Day 21
measure: Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14
timeFrame: Baseline and Day 2, Day 4, Day 7 and Day 14
measure: Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14
timeFrame: Day 2, Day 4, Day 7, Day 14
measure: Percentage of Participants Who Are Y-MRS Remitters at Day 21
timeFrame: Day 21
measure: Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21
timeFrame: Day 2, Day 4, Day 7, Day 14, Day 21
measure: Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and Day 7 and Day 21
measure: Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14
timeFrame: Baseline and Day 2, Day 4, Day 7, Day 14
measure: Change From Baseline in CGI-BP-S Mania Score
timeFrame: Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21
measure: Change From Baseline in CGI-BP-S Depression Score
timeFrame: Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21
measure: Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score
timeFrame: Day 2, Day 4, Day 7, Day 14, and Day 21
measure: Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score
timeFrame: Day 2, Day 4, Day 7, Day 14, and Day 21
measure: Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score
timeFrame: Day 2, Day 4, Day 7, Day 14, and Day 21
measure: Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline and Day 7, Day 14, Day 21
measure: Change From Baseline in PANSS Negative Subscale Score
timeFrame: Baseline and Day 7, Day 14, Day 21
measure: Change From Baseline in PANSS Positive Subscale Score
timeFrame: Baseline and Day 7, Day 14, Day 21
measure: Change From Baseline in PANSS General Psychopathology Subscale Score
timeFrame: Baseline and Day 7, Day 14, Day 21
measure: Change From Baseline in PANSS Marder Factor Positive Symptom Score
timeFrame: Baseline and Day 7, Day 14, Day 21
measure: Change From Baseline in PANSS Marder Factor Negative Symptom Score
timeFrame: Baseline and Day 7, Day 14, Day 21
measure: Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score
timeFrame: Baseline and Day 7, Day 14, Day 21
measure: Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score
timeFrame: Baseline and Day 7, Day 14, Day 21
measure: Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score
timeFrame: Baseline and Day 7, Day14, Day 21
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Landbloom RL, Mackle M, Wu X, Kelly L, Snow-Adami L, McIntyre RS, Mathews M, Hundt C. Asenapine: Efficacy and safety of 5 and 10mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder. J Affect Disord. 2016 Jan 15;190:103-110. doi: 10.1016/j.jad.2015.06.059. Epub 2015 Sep 25.