Back to results3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Asenapine
Olanzapine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
Inclusion Criteria: Have a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed. Exclusion Criteria: Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder as a primary diagnosis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Asenapine
Olanzapine
Placebo
Outcomes
Primary Outcome Measures
Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score
Secondary Outcome Measures
Change from Baseline to Day 21 in the Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) Severity of Mania
Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score
Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Readiness for Discharge Questionnaire (RDQ)
Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs
Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores
Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS)
Concomitant Medication Usage
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Change from Baseline to Each Time Point in YMRS Total Score
Change from Baseline to Day 21 in the CGI-BP Severity of Depression
Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness
Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores
Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21
Mean Change from Baseline for Vital Signs
Change from Baseline to Day 21 in Body Weight
Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values
Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values
Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values
Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values
Pharmacokinetics - Plasma asenapine concentrations
Full Information
NCT ID
NCT00159796
First Posted
September 8, 2005
Last Updated
February 2, 2022
Sponsor
Organon and Co
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00159796
Brief Title
3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)
Official Title
A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Safety and Efficacy of Sublingual Asenapine vs. Olanzapine and Placebo in In-Patients With an Acute Manic Episode Clinical Trial Protocol 7501005 (Secondary Title: ARES)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2004 (Actual)
Primary Completion Date
March 28, 2006 (Actual)
Study Completion Date
April 28, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. This is a 3-week study that will test the safety and efficacy of this medication. Participants will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Participants will be required to stay in the hospital for at least the first seven days of treatment. Participants who complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
489 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Asenapine
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Olanzapine
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Asenapine
Other Intervention Name(s)
Org 5222
Intervention Description
Asenapine, 3 weeks
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Olanzapine, 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo, 3 weeks
Primary Outcome Measure Information:
Title
Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score
Time Frame
Baseline to Day 21
Secondary Outcome Measure Information:
Title
Change from Baseline to Day 21 in the Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) Severity of Mania
Time Frame
Baseline to Day 21
Title
Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score
Time Frame
Baseline to Day 21
Title
Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Time Frame
Baseline to Day 21
Title
Readiness for Discharge Questionnaire (RDQ)
Time Frame
Baseline to Day 21
Title
Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs
Time Frame
Baseline to Day 21
Title
Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores
Time Frame
Baseline to Day 21
Title
Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS)
Time Frame
Baseline to Day 21
Title
Concomitant Medication Usage
Time Frame
Up to Day 21
Title
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Up to 30 days after last dose (Up to approximately 51 days)
Title
Change from Baseline to Each Time Point in YMRS Total Score
Time Frame
Days 2, 4, 7, 14, and 21
Title
Change from Baseline to Day 21 in the CGI-BP Severity of Depression
Time Frame
Baseline to Day 21
Title
Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness
Time Frame
Baseline to Day 21
Title
Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores
Time Frame
Baseline to Day 21
Title
Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21
Time Frame
Day 21
Title
Mean Change from Baseline for Vital Signs
Time Frame
Baseline up to Day 21
Title
Change from Baseline to Day 21 in Body Weight
Time Frame
Baseline to Day 21
Title
Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values
Time Frame
Up to Day 21
Title
Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values
Time Frame
Up to Day 21
Title
Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values
Time Frame
Up to Day 21
Title
Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values
Time Frame
Up to Day 21
Title
Pharmacokinetics - Plasma asenapine concentrations
Time Frame
Day 1 (pre-dose), 7, 14 and 21 (or endpoint)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.
Exclusion Criteria:
Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder as a primary diagnosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
29105003
Citation
Suppes T, Eberhard J, Lemming O, Young AH, McIntyre RS. Anxiety, irritability, and agitation as indicators of bipolar mania with depressive symptoms: a post hoc analysis of two clinical trials. Int J Bipolar Disord. 2017 Nov 6;5(1):36. doi: 10.1186/s40345-017-0103-7.
Results Reference
derived
PubMed Identifier
24329543
Citation
Michalak EE, Guiraud-Diawara A, Sapin C. Asenapine treatment and health-related quality of life in patients experiencing bipolar I disorder with mixed episodes: post-hoc analyses of pivotal trials. Curr Med Res Opin. 2014 Apr;30(4):711-8. doi: 10.1185/03007995.2013.874988. Epub 2014 Jan 10.
Results Reference
derived
PubMed Identifier
23473546
Citation
Szegedi A, Zhao J, McIntyre RS. Early improvement as a predictor of acute treatment outcome in manic or mixed episodes in bipolar-1 disorder: a pooled, post hoc analysis from the asenapine development program. J Affect Disord. 2013 Sep 25;150(3):745-52. doi: 10.1016/j.jad.2013.01.024. Epub 2013 Mar 6.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)
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