3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)
NCT00159744
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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 DSMIV 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
- 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.
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Advanced Information
| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | 3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008) | ||
| 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 7501004 (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. 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. | ||
| 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 |
| ||
| Study Arms ICMJE |
| ||
| 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 | 488 | ||
| Original Enrollment ICMJE | 480 | ||
| Actual Study Completion Date ICMJE | April 29, 2006 | ||
| Actual Primary Completion Date | April 29, 2006 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| 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, Ukraine, United States | ||
| Administrative Information | |||
| NCT Number ICMJE | NCT00159744 | ||
| Other Study ID Numbers ICMJE | P07008 A7501004 ( 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 | |||