3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (A7501004)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Organon
ClinicalTrials.gov Identifier:
NCT00159744
First received: September 8, 2005
Last updated: August 11, 2008
Last verified: August 2008
  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. 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Organon:

Primary Outcome Measures:
  • Changes in bipolar manic or mixed symptoms reflected in the scores on the YMRS (Young Mania Rating Scale) [ Time Frame: The YMRS was administered at screening, baseline, Day 2, 4, 7, 14 and 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratings on the Clinical Global Impression scale in which severity and improvement of mania, depression, and overall bipolar state are rated. [ Time Frame: The CGI assessment at days 1,7 and endpoint (day 21 or the time of the last assessment). ] [ Designated as safety issue: No ]
  • The PANSS (Positive and Negative Symptom Scale) was used to assess psychotic symptoms [ Time Frame: The PANSS was administered at Days 1, 7 and 21(or the time of the last assessment). ] [ Designated as safety issue: No ]
  • The MADRS (Montgomery Asberg Depression Rating Scale) was used to assess depressive symptoms [ Time Frame: The MADRS was administered on Days 1, 7 and 21(or at the time of the last assessment).l ] [ Designated as safety issue: No ]
  • The Readiness for Discharge Questionaire (RDQ) was administered to characterize the subject's readiness for discharge. The investigator was to make the decision about discharging the subject. [ Time Frame: The RDQ was administered on Day 1, 2, 4, 7 , 14 and 21 (or at the time of the last assessment) ] [ Designated as safety issue: No ]
  • CogState, cognition battery, was used to assess changes in cognition [ Time Frame: Cog State was administered at screening, Day 1 (baseline) and Days 7, 14, 21 (or endpoint). ] [ Designated as safety issue: No ]
  • SF (short form)-36 and TSQM (Treatment Satisfaction Questionnaire for Medication) -- 2 measures of Quality of Life were administered. [ Time Frame: The SF Health Survey was administered at Day 1 and Day 21 or endpoint. The TSMQ was administered at Day 21 or endpoint.. ] [ Designated as safety issue: No ]
  • The SARS (Simpson Angus Rating Scale); the AIMS (Involuntary Movement Scale and the BARS (Barnes Akathisia Scale) were used to assess extrapyramidal symptoms [ Time Frame: The SARS, AIMS and BARS assessments were administered at Days 1, 7 and 21 or endpoint. ] [ Designated as safety issue: No ]
  • Concomitant medication use was recorded [ Time Frame: Concomitant medication use was recorded whenever it occurred ] [ Designated as safety issue: No ]
  • Physical examination, laboratory and electrocardiogram findings and weight/abdominal girth and vital signs were recorded. [ Time Frame: Physical exam, ECG, laboratory and weight were recorded at screening and Day 21 or endpoint. Laboratory work was also done at baseline. ] [ Designated as safety issue: No ]
  • Adverse events (AEs) [ Time Frame: AEs were recorded whenever they occurred.. ] [ Designated as safety issue: No ]
  • Pharmacokinetic analysis was done to determine the level of the drug in the blood [ Time Frame: Pk samples were taken at Day 1, 7, 14 and 21 (or endpoint). ] [ Designated as safety issue: No ]

Enrollment: 488
Study Start Date: November 2004
Study Completion Date: April 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Asenapine
Drug: Asenapine
Asenapine, 3 weeks
Other Name: Org 5222
Active Comparator: Arm 2
Olanzapine
Drug: Olanzapine
Olanzapine, 3 weeks
Placebo Comparator: Arm 3
Placebo
Drug: Placebo
placebo, 3 weeks

  Eligibility

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

Inclusion Criteria:

  • Have a DSMIV diagnosis of bipolar I disorder, current episode manic or mixed.

Exclusion Criteria:

  • 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.
  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 Organon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, NV Organon, part of Schering-Plough Corporation
ClinicalTrials.gov Identifier: NCT00159744     History of Changes
Other Study ID Numbers: A7501004
Study First Received: September 8, 2005
Last Updated: August 11, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2014