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3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159744
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 31, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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. 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Asenapine Drug: Olanzapine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 7501004 (Secondary Title: ARES)
Actual Study Start Date : November 30, 2004
Actual Primary Completion Date : April 29, 2006
Actual Study Completion Date : April 29, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Active Comparator: Arm 1
Drug: Asenapine
Asenapine, 3 weeks
Other Name: Org 5222

Active Comparator: Arm 2
Drug: Olanzapine
Olanzapine, 3 weeks

Placebo Comparator: Arm 3
Drug: Placebo
placebo, 3 weeks

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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). ]
  2. 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). ]
  3. 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 ]
  4. 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) ]
  5. CogState, cognition battery, was used to assess changes in cognition [ Time Frame: Cog State was administered at screening, Day 1 (baseline) and Days 7, 14, 21 (or endpoint). ]
  6. 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.. ]
  7. 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. ]
  8. Concomitant medication use was recorded [ Time Frame: Concomitant medication use was recorded whenever it occurred ]
  9. 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. ]
  10. Adverse events (AEs) [ Time Frame: AEs were recorded whenever they occurred.. ]
  11. 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). ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Study Data/Documents: CSR Synopsis  This link exits the site

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00159744    
Other Study ID Numbers: P07008
A7501004 ( Other Identifier: Schering-Plough )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents