40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED) - Full Text View

Sponsors and Collaborators:	Organon Pfizer
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00159783

Purpose

Bipolar disorder is characterized by mood swings that range from 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 study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.

Condition	Intervention	Phase
Bipolar Disorder	Drug: asenapine Drug: Olanzapine	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, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, 40-Week Continuation Study Evaluating the Safety of Asenapine and Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501007 (Secondary Title: ARES)

Further study details as provided by Organon:

Primary Outcome Measures:

Safety (each measure of safety specified below) of asenapine in the treatment of patients with bipolar mania [ Time Frame: Up to one year (including the short term studies -- 3 weeks; the extension study -- 9 weeks; and this 40 week study ] [ Designated as safety issue: No ]
Physical exam and ECG findings [ Time Frame: Physical exam and ECG findings done at Week 40 or endpoint ] [ Designated as safety issue: No ]
Adverse events, including extrapyramidal symptoms (assessed using the AIMS [involuntary movement scale] the BARS [Barnes Akathisia Rating Scale] and the SARS [Simpson Angus Rating Scale] and concomitant medications were recorded . [ Time Frame: Adverse events (with the exception of EPS) and concomitant medications were recorded at each visit (Wks 1,4,8,12,16,20,24,28,32,36 and 40 or endpoint). EPS were recorded at Wks 12 and 40 or endpoint. ] [ Designated as safety issue: Yes ]
Body weight and abdominal girth, vital signs, laboratory values. [ Time Frame: Body weight and abdominal girth and vital signs done at Wks 4,12,20,28 and 40 or endpoint. Blood chemistry and hematology done at Wks 12 and 40 or endpoint; and urinalysis done at Wk 40 or endpoint. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptoms of mania (as measured by the Young Mania Rating Scale [YMRS]) depression (as measured by the Montgomery Asberg Rating scale [MADRS]) [ Time Frame: YMRS and MADRS wks 4, 12, 20,28 and 40 or endpoint. ] [ Designated as safety issue: No ]
Readiness to discharge (RDQ) and Quality of Life (Short Form-36) and TSQM (Treatment Satisfaction Questionnaire about Medicine) [ Time Frame: RDQ administered at each visit at which the patient was an inpatient; The SF-36 and the TSQM at wks 12, 28 and 40 or endpoint. ] [ Designated as safety issue: No ]
Cognition as measured by CNS Vitals Signs(subjects who participated in the short term studies for which this is an extension) [A7501005] or Cog State (subjects who participated in A7501004).and Living, Employment and Arrest History [ Time Frame: Cognition and Living, Employment and Arrest History were assessed at wks 12, 20, 28 and 40 or endpoint. ] [ Designated as safety issue: No ]
Clinical Global Impression (CGI) scale is used to rate mania, depression and overall status in terms of severity and improvement. [ Time Frame: The CGI is administered at wks 4, 12, 20,28 and 40 or endpoint. ] [ Designated as safety issue: No ]
Psychosis (as measured by the Positive and Negative Symptoms Scale [PANSS]), and suicidal thinking as measured by the [ISST] (InterSept Scale of Suicidal Thinking). [ Time Frame: PANSS, wk 40 or endpoint; ISST -wks 12, 28 and 40 or endpoint. ] [ Designated as safety issue: No ]

Enrollment:	218
Study Start Date:	July 2005
Study Completion Date:	April 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental asenapine	Drug: asenapine Asenapine, 40 weeks
Arm 2: Active Comparator Olanzapine	Drug: Olanzapine Olanzapine, 40 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..

Exclusion Criteria:

Patients with unstable medical conditions or clinically significant laboratory abnormalities.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	A7501007
Study First Received:	September 8, 2005
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00159783
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
Disease
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
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009