3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

NCT00159796

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Have a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Participants with unstable medical conditions or clinically significant laboratory
abnormalities or participants who are rapid cyclers (i.e., 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)
Official Title  ICMJE 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)
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. Participants will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Participants will be required to stay in the hospital for at least the first seven days of treatment. Participants who complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: 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, 3 weeks
    Other Name: Org 5222
  • Drug: Olanzapine
    Olanzapine, 3 weeks
  • Drug: Placebo
    placebo, 3 weeks
Study Arms  ICMJE
  • Experimental: Arm 1
    Asenapine
    Intervention: Drug: Asenapine
  • Active Comparator: Arm 2
    Olanzapine
    Intervention: Drug: Olanzapine
  • Placebo Comparator: Arm 3
    Placebo
    Intervention: Drug: Placebo
Publications *

*   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 11, 2008)
489
Original Enrollment  ICMJE
 (submitted: September 10, 2005)
480
Actual Study Completion Date  ICMJE April 28, 2006
Actual Primary Completion Date March 28, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.

Exclusion Criteria:

  • Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., 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.
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 NCT00159796
Other Study ID Numbers  ICMJE P07009
A7501005 ( 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
Study Director:Medical DirectorMerck Sharp & Dohme Corp.
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