9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (A7501006)(COMPLETED) - Full Text View

Sponsors and Collaborators:	Organon Pfizer
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00143182

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. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.

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, 9-Week Extension Study Evaluating the Safety and Maintenance of Effect of Asenapine vs. Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501006 (Secondary Title: ARES)

Further study details as provided by Organon:

Primary Outcome Measures:

Maintenance of the effect (Asenapine comparable to olanzapine in terms of the reduction of symptoms achieved in the short term (ie. 3 week studies [A7501004 or A7501005]) as measured on the Young Mania Rating Scale [ Time Frame: The YMRS is administered at weeks 1, 3, 6 and 9 or endpoint. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes on the Clinical Global Impression Scale in which Mania, Depression and Overall Status were assessed. [ Time Frame: The Global assessment at Weeks 1,3, 6 and 9 or endpoint ] [ Designated as safety issue: No ]
Improvement in symptoms of depression (measured by the Montgomery Asberg Rating Scale of Depression - the MADRS), psychoses (Positive and Negative Symptoms Scale -- the PANSS) and suicidality (ISST-- The InsterSept Suicidality Scale) [ Time Frame: PANSS and MADRS administered at weeks 1,3,6 and 9 or endpoint; ISST administered at Weeks 1 and 6. ] [ Designated as safety issue: No ]
Changes in the Quality of Life and the TSQM and changes in Readiness to Discharge Questionaire [RDQ]. The investigator's judgment was the basis for a decision to discharge the subject from the hospital. [ Time Frame: Quality of Life measures were administered at week 9 or endpoint and the RDQ was administered to inpatients at week 1, 3, 6 and 9.or endpoint. ] [ Designated as safety issue: No ]
Physical exams and electrocardiograms findings; changes in vital signs, weight and abdominal girth and hematology and urinalysis. [ Time Frame: Physical exams and ECGs at Week 9 or endpoint; Vital signs, weight and abdominal girth at weeks 1, 3, 6 and 9 or endpoint; hematological parameters assessed at weeks 1 and 9 or endpoint; urinalysis was done at Week 9 or endpoint. ] [ Designated as safety issue: No ]
Cognition -- the cognitive battery was the same battery that the subject had in the short term study in which they participated -- CNS Vital Signs for A7501005 and Cogstate for A7501004. [ Time Frame: The cognitive battery was done at Week 9 or endpoint ] [ Designated as safety issue: No ]
Extrapyramidal symptoms were assessed using the AIMS (Involuntary Movement Scale); the BARS (Barnes Akathisia Rating Scale) and the SARS (Simpson Angus Rating Scale). [ Time Frame: Extrapyramidal symptoms were assessed at Week 9 or endpoint. ] [ Designated as safety issue: No ]
Adverse events and concomitant medications were recorded [ Time Frame: Recorded at each visit (Weeks 1, 3, 6, 9 and endpoint) ] [ Designated as safety issue: Yes ]

Enrollment:	504
Study Start Date:	January 2005
Study Completion Date:	June 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Asenapine	Drug: Asenapine Asenapine , 9 weeks
2: Active Comparator Olanzapine	Drug: Olanzapine Olanzapine, 9 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Have completed an asenapine 3-week study for the treatment of an acute manic or mixed episode and not had a major protocol violation.in the short term study (A7501004 or A7501005) that they completed.

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:	A7501006
Study First Received:	August 31, 2005
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00143182
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 16, 2009