3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (A7501005)(COMPLETED) - Full Text View

Sponsors and Collaborators:	Organon Pfizer
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00159796

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 III

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Olanzapine Org 5222

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 7501005 (Secondary Title: ARES)

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 ]
CNS vital signs, cognition battery, was used to assess changes in cognition [ Time Frame: CNS vital signs 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:	489
Study Start Date:	December 2004
Study Completion Date:	April 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator Asenapine	Drug: Asenapine Asenapine, 3 weeks
Arm 2: Active Comparator Olanzapine	Drug: Olanzapine Olanzapine, 3 weeks
Arm 3: Placebo Comparator 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

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	A7501005
Study First Received:	September 8, 2005
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00159796
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Olanzapine

Mood Disorders
Neoplasm Metastasis
Psychotic Disorders
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009