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Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar 1 Disorder

Intervention: Asenapine (Drug); Asenapine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21

Secondary outcome:

Change From Baseline in Clinical Global Impression - Bipolar Mania - Severity of Illness (CGI-BP-S) Overall Score at Day 21

Percentage of Participants Who Are Y-MRS Responders at Day 21

Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14

Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14

Percentage of Participants Who Are Y-MRS Remitters at Day 21

Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21

Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score

Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14

Change From Baseline in CGI-BP-S Mania Score

Change From Baseline in CGI-BP-S Depression Score

Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score

Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score

Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score

Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score

Change From Baseline in PANSS Negative Subscale Score

Change From Baseline in PANSS Positive Subscale Score

Change From Baseline in PANSS General Psychopathology Subscale Score

Change From Baseline in PANSS Marder Factor Positive Symptom Score

Change From Baseline in PANSS Marder Factor Negative Symptom Score

Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score

Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score

Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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-TRâ„¢) 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).

Locations and Contacts

Additional Information

Starting date: April 2012
Last updated: April 8, 2015

Page last updated: August 23, 2015

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