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9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)

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: NCT00143182
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : February 4, 2022
Information provided by (Responsible Party):
Organon and Co

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. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 504 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, 9-Week Extension Study Evaluating the Safety and Maintenance of Effect of Asenapine vs. Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501006 (Secondary Title: ARES)
Actual Study Start Date : January 7, 2005
Actual Primary Completion Date : June 28, 2006
Actual Study Completion Date : June 28, 2006

Arm Intervention/treatment
Experimental: 1
Drug: Asenapine
Asenapine , 9 weeks
Other Name: Org 5222

Active Comparator: 2
Drug: Olanzapine
Olanzapine, 9 weeks

Primary Outcome Measures :
  1. Maintenance of the effect (Asenapine comparable to olanzapine in terms of the reduction of symptoms achieved in the short term (ie. 3 week studies [A7501004 or A7501005]) as measured on the Young Mania Rating Scale [ Time Frame: The YMRS is administered at weeks 1, 3, 6 and 9 or endpoint. ]

Secondary Outcome Measures :
  1. Changes on the Clinical Global Impression Scale in which Mania, Depression and Overall Status were assessed. [ Time Frame: The Global assessment at Weeks 1,3, 6 and 9 or endpoint ]
  2. Improvement in symptoms of depression (measured by the Montgomery Asberg Rating Scale of Depression - the MADRS), psychoses (Positive and Negative Symptoms Scale -- the PANSS) and suicidality (ISST-- The InsterSept Suicidality Scale) [ Time Frame: PANSS and MADRS administered at weeks 1,3,6 and 9 or endpoint; ISST administered at Weeks 1 and 6. ]
  3. Changes in the Quality of Life and the TSQM and changes in Readiness to Discharge Questionaire [RDQ]. The investigator's judgment was the basis for a decision to discharge the subject from the hospital. [ Time Frame: Quality of Life measures were administered at week 9 or endpoint and the RDQ was administered to inpatients at week 1, 3, 6 and 9.or endpoint. ]
  4. Physical exams and electrocardiograms findings; changes in vital signs, weight and abdominal girth and hematology and urinalysis. [ Time Frame: Physical exams and ECGs at Week 9 or endpoint; Vital signs, weight and abdominal girth at weeks 1, 3, 6 and 9 or endpoint; hematological parameters assessed at weeks 1 and 9 or endpoint; urinalysis was done at Week 9 or endpoint. ]
  5. Cognition -- the cognitive battery was the same battery that the subject had in the short term study in which they participated -- CNS Vital Signs for A7501005 and Cogstate for A7501004. [ Time Frame: The cognitive battery was done at Week 9 or endpoint ]
  6. Extrapyramidal symptoms were assessed using the AIMS (Involuntary Movement Scale); the BARS (Barnes Akathisia Rating Scale) and the SARS (Simpson Angus Rating Scale). [ Time Frame: Extrapyramidal symptoms were assessed at Week 9 or endpoint. ]
  7. Adverse events and concomitant medications were recorded [ Time Frame: Recorded at each visit (Weeks 1, 3, 6, 9 and 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 completed an asenapine 3-week study for the treatment of an acute manic or mixed episode and not had a major protocol the short term study (A7501004 or A7501005) that they completed.

Exclusion Criteria:

  • Patients with unstable medical conditions or clinically significant laboratory abnormalities.
Study Data/Documents: CSR Synopsis  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Organon and Co Identifier: NCT00143182    
Other Study ID Numbers: P07007
A7501006 ( Other Identifier: Schering-Plough )
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: February 2022
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