Clinical trial NCT00145470: 12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)
Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 326
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 is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.


Eligibility criteria: Inclusion Criteria:

* Have bipolar I disorder, current episode manic or mixed
* Treated with lithium or valproic acid

Exclusion Criteria:

* Have an unstable medical condition
* Clinically significant laboratory abnormality.
* Have a primary diagnosis other than bipolar I disorder.

Primary outcomes:
measure: Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21
timeFrame: Baseline and Day 21
Secondary outcomes:
measure: Number of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to Day 114
measure: Number of Participants Discontinuing Study Treatment Due to an AE
timeFrame: Up to Day 84
measure: Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 42
timeFrame: Baseline and Day 42
measure: Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 84
timeFrame: Baseline and Day 84
measure: Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Responder Status
timeFrame: Up to Day 84
measure: Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Remitter Status
timeFrame: Up to Day 84
measure: Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Mania Score at Day 21
timeFrame: Baseline and Day 21
measure: Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Mania Score at Day 84
timeFrame: Baseline and Day 84
measure: Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Depression Score at Day 21
timeFrame: Baseline and Day 21
measure: Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Depression Score at Day 84
timeFrame: Baseline and Day 84
measure: Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Overall Bipolar Illness Score at Day 21
timeFrame: Baseline and Day 21
measure: Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Overall Bipolar Illness Score at Day 84
timeFrame: Baseline and Day 84
measure: Least Squares Mean Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score at Day 21
timeFrame: Baseline and Day 21
measure: Least Squares Mean Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score at Day 84
timeFrame: Baseline and Day 84
measure: Least Squares Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Day 21
timeFrame: Baseline and Day 21
measure: Least Squares Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Day 84
timeFrame: Baseline and Day 84
measure: Least Squares Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Day 21
timeFrame: Baseline and Day 21
measure: Least Squares Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Day 84
timeFrame: Baseline and Day 84
measure: Least Squares Mean Change From Baseline in InterSePT Scale for Suicidal Thinking - Modified Version (ISST-Modified) Score at Day 21
timeFrame: Baseline and Day 21
measure: Least Squares Mean Change From Baseline in InterSePT Scale for Suicidal Thinking - Modified Version (ISST-Modified) Score at Day 84
timeFrame: Baseline and Day 84
measure: Mean Change From Baseline (CFB) at Day 21 in Neurocognitive Function as Determined by Central Nervous System Vital Signs (CNS-VS) Test Battery
timeFrame: Baseline and Day 21
measure: Mean Change From Baseline (CFB) at Day 84 in Neurocognitive Function as Determined by Central Nervous System Vital Signs (CNS-VS) Test Battery
timeFrame: Baseline and Day 84
measure: Percentage of Participants Determined to be Ready to Discharge at Day 84 (Kaplan-Meier Estimation)
timeFrame: Day 84
measure: Least Squares Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), General Activities Subscale Score at Day 21
timeFrame: Baseline and Day 21
measure: Least Squares Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), General Activities Subscale Score at Day 84
timeFrame: Baseline and Day 84
measure: Least Squares Mean Change From Baseline at Day 21 in Quality of Life as Determined by Short Form-36 Version 2 (SF-36v2)
timeFrame: Baseline and Day 21
measure: Least Squares Mean Change From Baseline at Day 84 in Quality of Life as Determined by Short Form-36 Version 2 (SF-36v2)
timeFrame: Baseline and Day 21
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012 Feb;32(1):46-55. doi: 10.1097/JCP.0b013e31823f872f.