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3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00159796
First received: September 8, 2005
Last updated: September 21, 2015
Last verified: September 2015

September 8, 2005
September 21, 2015
December 2004
March 2006   (final data collection date for primary outcome measure)
Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
Improvement in bipolar manic or mixed episodes
Complete list of historical versions of study NCT00159796 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Readiness for Discharge Questionnaire (RDQ) [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS) [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: Yes ]
  • Concomitant Medication Usage [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after last dose (Up to approximately 51 days) ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Each Time Point in YMRS Total Score [ Time Frame: Days 2, 4, 7, 14, and 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in the CGI-BP Severity of Depression [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21 [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Mean Change from Baseline for Vital Signs [ Time Frame: Baseline up to Day 21 ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Day 21 in Body Weight [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: Yes ]
  • Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics - Plasma asenapine concentrations [ Time Frame: Day 1 (pre-dose), 7, 14 and 21 (or endpoint) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Asenapine
    Asenapine, 3 weeks
    Other Name: Org 5222
  • Drug: Olanzapine
    Olanzapine, 3 weeks
  • Drug: Placebo
    placebo, 3 weeks
  • Experimental: Arm 1
    Asenapine
    Intervention: Drug: Asenapine
  • Active Comparator: Arm 2
    Olanzapine
    Intervention: Drug: Olanzapine
  • Placebo Comparator: Arm 3
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
489
April 2006
March 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Bulgaria,   India,   Korea, Republic of,   Malaysia,   Philippines,   Romania,   Russian Federation,   Turkey,   Ukraine,   United States
 
NCT00159796
P07009, A7501005
Yes
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Pfizer
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP