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

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ClinicalTrials.gov Identifier: NCT00143182
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date May 31, 2017
Actual Study Start Date  ICMJE January 7, 2005
Actual Primary Completion Date June 28, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
To assess the safety and efficacy of SU11248 in patients with neuroendocrine tumors.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
  • 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 ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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 ]
  • 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. ]
  • Adverse events and concomitant medications were recorded [ Time Frame: Recorded at each visit (Weeks 1, 3, 6, 9 and endpoint) ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: Asenapine
    Asenapine , 9 weeks
    Other Name: Org 5222
  • Drug: Olanzapine
    Olanzapine, 9 weeks
Study Arms  ICMJE
  • Experimental: 1
    Asenapine
    Intervention: Drug: Asenapine
  • Active Comparator: 2
    Olanzapine
    Intervention: Drug: Olanzapine
Publications * McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord. 2009 Dec;11(8):815-26. doi: 10.1111/j.1399-5618.2009.00749.x. Epub 2009 Oct 14. Erratum in: Bipolar Disord. 2010 Feb;12(1):112.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2008)
504
Original Enrollment  ICMJE
 (submitted: August 31, 2005)
109
Actual Study Completion Date  ICMJE June 28, 2006
Actual Primary Completion Date June 28, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Bulgaria,   India,   Korea, Republic of,   Malaysia,   Philippines,   Romania,   Russian Federation,   Turkey,   Ukraine,   United States
 
Administrative Information
NCT Number  ICMJE NCT00143182
Other Study ID Numbers  ICMJE P07007
A7501006 ( Other Identifier: Schering-Plough )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017

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