3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)

Bipolar Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159744
• Other study ID #: P07008
• Secondary ID: A7501004
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2004
• Est. completion date: April 29, 2006

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: April 29, 2006
• Est. primary completion date: April 29, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Asenapine
Asenapine, 3 weeks
• Olanzapine
Olanzapine, 3 weeks
• Placebo
placebo, 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Pfizer

References & Publications (1)

McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord. 2010 Apr;122(1-2):27-38. doi: 10.1016/j.jad.2009.12.028. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in bipolar manic or mixed symptoms reflected in the scores on the YMRS (Young Mania Rating Scale)		The YMRS was administered at screening, baseline, Day 2, 4, 7, 14 and 21
Secondary	Ratings on the Clinical Global Impression scale in which severity and improvement of mania, depression, and overall bipolar state are rated.		The CGI assessment at days 1,7 and endpoint (day 21 or the time of the last assessment).
Secondary	The PANSS (Positive and Negative Symptom Scale) was used to assess psychotic symptoms		The PANSS was administered at Days 1, 7 and 21(or the time of the last assessment).
Secondary	The MADRS (Montgomery Asberg Depression Rating Scale) was used to assess depressive symptoms		The MADRS was administered on Days 1, 7 and 21(or at the time of the last assessment).l
Secondary	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.		The RDQ was administered on Day 1, 2, 4, 7 , 14 and 21 (or at the time of the last assessment)
Secondary	CogState, cognition battery, was used to assess changes in cognition		Cog State was administered at screening, Day 1 (baseline) and Days 7, 14, 21 (or endpoint).
Secondary	SF (short form)-36 and TSQM (Treatment Satisfaction Questionnaire for Medication) -- 2 measures of Quality of Life were administered.		The SF Health Survey was administered at Day 1 and Day 21 or endpoint. The TSMQ was administered at Day 21 or endpoint..
Secondary	The SARS (Simpson Angus Rating Scale); the AIMS (Involuntary Movement Scale and the BARS (Barnes Akathisia Scale) were used to assess extrapyramidal symptoms		The SARS, AIMS and BARS assessments were administered at Days 1, 7 and 21 or endpoint.
Secondary	Concomitant medication use was recorded		Concomitant medication use was recorded whenever it occurred
Secondary	Physical examination, laboratory and electrocardiogram findings and weight/abdominal girth and vital signs were recorded.		Physical exam, ECG, laboratory and weight were recorded at screening and Day 21 or endpoint. Laboratory work was also done at baseline.
Secondary	Adverse events (AEs)		AEs were recorded whenever they occurred..
Secondary	Pharmacokinetic analysis was done to determine the level of the drug in the blood		Pk samples were taken at Day 1, 7, 14 and 21 (or endpoint).