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3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (A7501005)(COMPLETED)

This study has been completed.
Information provided by:
Organon Identifier:
First received: September 8, 2005
Last updated: August 11, 2008
Last verified: August 2008

September 8, 2005
August 11, 2008
December 2004
March 2006   (final data collection date for primary outcome measure)
Changes in bipolar manic or mixed symptoms reflected in the scores on the YMRS (Young Mania Rating Scale) [ Time Frame: The YMRS was administered at screening, baseline, Day 2, 4, 7, 14 and 21 ] [ Designated as safety issue: No ]
Improvement in bipolar manic or mixed episodes
Complete list of historical versions of study NCT00159796 on Archive Site
  • Ratings on the Clinical Global Impression scale in which severity and improvement of mania, depression, and overall bipolar state are rated. [ Time Frame: The CGI assessment at days 1,7 and endpoint (day 21 or the time of the last assessment). ] [ Designated as safety issue: No ]
  • The PANSS (Positive and Negative Symptom Scale) was used to assess psychotic symptoms [ Time Frame: The PANSS was administered at Days 1, 7 and 21(or the time of the last assessment). ] [ Designated as safety issue: No ]
  • The MADRS (Montgomery Asberg Depression Rating Scale) was used to assess depressive symptoms [ Time Frame: The MADRS was administered on Days 1, 7 and 21(or at the time of the last assessment).l ] [ Designated as safety issue: No ]
  • The Readiness for Discharge Questionaire (RDQ) was administered to characterize the subject's readiness for discharge. The investigator was to make the decision about discharging the subject. [ Time Frame: The RDQ was administered on Day 1, 2, 4, 7 , 14 and 21 (or at the time of the last assessment) ] [ Designated as safety issue: No ]
  • CNS vital signs, cognition battery, was used to assess changes in cognition [ Time Frame: CNS vital signs was administered at screening, Day 1 (baseline) and Days 7, 14, 21 (or endpoint). ] [ Designated as safety issue: No ]
  • SF (short form)-36 and TSQM (Treatment Satisfaction Questionnaire for Medication) -- 2 measures of Quality of Life were administered. [ Time Frame: The SF Health Survey was administered at Day 1 and Day 21 or endpoint. The TSMQ was administered at Day 21 or endpoint.. ] [ Designated as safety issue: No ]
  • The SARS (Simpson Angus Rating Scale); the AIMS (Involuntary Movement Scale and the BARS (Barnes Akathisia Scale) were used to assess extrapyramidal symptoms [ Time Frame: The SARS, AIMS and BARS assessments were administered at Days 1, 7 and 21 or endpoint. ] [ Designated as safety issue: No ]
  • Concomitant medication use was recorded [ Time Frame: Concomitant medication use was recorded whenever it occurred ] [ Designated as safety issue: No ]
  • Physical examination, laboratory and electrocardiogram findings and weight/abdominal girth and vital signs were recorded. [ Time Frame: Physical exam, ECG, laboratory and weight were recorded at screening and Day 21 or endpoint. Laboratory work was also done at baseline. ] [ Designated as safety issue: No ]
  • Adverse events (AEs) [ Time Frame: AEs were recorded whenever they occurred.. ] [ Designated as safety issue: No ]
  • Pharmacokinetic analysis was done to determine the level of the drug in the blood [ Time Frame: Pk samples were taken at Day 1, 7, 14 and 21 (or endpoint). ] [ Designated as safety issue: No ]
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3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (A7501005)(COMPLETED)
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. Patients will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Patients will be required to stay in the hospital for at least the first seven days of treatment. Patients that 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
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
  • Active Comparator: Arm 1
    Intervention: Drug: Asenapine
  • Active Comparator: Arm 2
    Intervention: Drug: Olanzapine
  • Placebo Comparator: Arm 3
    Intervention: Drug: Placebo

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

Inclusion Criteria:

  • Have a DSMIV diagnosis of bipolar I disorder, current episode manic or mixed.

Exclusion Criteria:

  • Patients with unstable medical conditions or clinically significant laboratory abnormalities or patients who are rapid cyclers (ie. 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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Study Director, NV Organon, part of Schering-Plough Corporation
Not Provided
August 2008

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