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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00143182
First received: August 31, 2005
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Bipolar Disorder
Drug: Asenapine
Drug: Olanzapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Adverse events and concomitant medications were recorded [ Time Frame: Recorded at each visit (Weeks 1, 3, 6, 9 and endpoint) ] [ Designated as safety issue: Yes ]

Enrollment: 504
Study Start Date: January 2005
Study Completion Date: June 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Asenapine
Drug: Asenapine
Asenapine , 9 weeks
Other Name: Org 5222
Active Comparator: 2
Olanzapine
Drug: Olanzapine
Olanzapine, 9 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 violation.in the short term study (A7501004 or A7501005) that they completed.

Exclusion Criteria:

  • Patients with unstable medical conditions or clinically significant laboratory abnormalities.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00143182     History of Changes
Other Study ID Numbers: P07007, A7501006
Study First Received: August 31, 2005
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Asenapine
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2014