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

NCT00159744 | Completed Phase 3 DMC

• 2 other identifiers: P07008A7501004
• Study Type: interventional
• Target: 488
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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).

• 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).

• 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

• 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)

• 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).

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Asenapine

Drug: Asenapine

Arm 2

ACTIVE COMPARATOR

Olanzapine

Drug: Olanzapine

Arm 3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Asenapine DRUG

Asenapine, 3 weeks

Also known as: Org 5222

Arm 1

Olanzapine DRUG

Olanzapine, 3 weeks

Arm 2

Placebo DRUG

placebo, 3 weeks

Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead
• Pfizer: collaborator

Related Publications (4)

• 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. Epub 2010 Jan 22.

  PMID: 20096936 RESULT

• Suppes T, Eberhard J, Lemming O, Young AH, McIntyre RS. Anxiety, irritability, and agitation as indicators of bipolar mania with depressive symptoms: a post hoc analysis of two clinical trials. Int J Bipolar Disord. 2017 Nov 6;5(1):36. doi: 10.1186/s40345-017-0103-7.

  PMID: 29105003 DERIVED

• Michalak EE, Guiraud-Diawara A, Sapin C. Asenapine treatment and health-related quality of life in patients experiencing bipolar I disorder with mixed episodes: post-hoc analyses of pivotal trials. Curr Med Res Opin. 2014 Apr;30(4):711-8. doi: 10.1185/03007995.2013.874988. Epub 2014 Jan 10.

  PMID: 24329543 DERIVED

• Szegedi A, Zhao J, McIntyre RS. Early improvement as a predictor of acute treatment outcome in manic or mixed episodes in bipolar-1 disorder: a pooled, post hoc analysis from the asenapine development program. J Affect Disord. 2013 Sep 25;150(3):745-52. doi: 10.1016/j.jad.2013.01.024. Epub 2013 Mar 6.

  PMID: 23473546 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

asenapine; Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: November 30, 2004
• Primary Completion: April 29, 2006
• Study Completion: April 29, 2006
• Last Updated: August 15, 2024

Record last verified: 2022-02