NCT00159796

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. Participants will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Participants will be required to stay in the hospital for at least the first seven days of treatment. Participants who complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
489

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2006

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

September 8, 2005

Last Update Submit

August 13, 2024

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score

    Baseline to Day 21

Secondary Outcomes (21)

  • Change from Baseline to Day 21 in the Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) Severity of Mania

    Baseline to Day 21

  • Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score

    Baseline to Day 21

  • Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score

    Baseline to Day 21

  • Readiness for Discharge Questionnaire (RDQ)

    Baseline to Day 21

  • Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs

    Baseline to Day 21

  • +16 more secondary outcomes

Study Arms (3)

Arm 1

EXPERIMENTAL

Asenapine

Drug: Asenapine

Arm 2

ACTIVE COMPARATOR

Olanzapine

Drug: Olanzapine

Arm 3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AsenapineDRUG

Asenapine, 3 weeks

Also known as: Org 5222
Arm 1
OlanzapineDRUG

Olanzapine, 3 weeks

Arm 2
PlaceboDRUG

placebo, 3 weeks

Arm 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.

You may not qualify if:

  • Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 29105003DERIVED

  • 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: 24329543DERIVED

  • 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: 23473546DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

asenapineOlanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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

December 14, 2004

Primary Completion

March 28, 2006

Study Completion

April 28, 2006

Last Updated

August 15, 2024

Record last verified: 2022-02