NCT00143182

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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
504

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2005

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

January 7, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2006

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

August 31, 2005

Last Update Submit

August 13, 2024

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

    The YMRS is administered at weeks 1, 3, 6 and 9 or endpoint.

Secondary Outcomes (7)

  • Changes on the Clinical Global Impression Scale in which Mania, Depression and Overall Status were assessed.

    The Global assessment at Weeks 1,3, 6 and 9 or endpoint

  • 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)

    PANSS and MADRS administered at weeks 1,3,6 and 9 or endpoint; ISST administered at Weeks 1 and 6.

  • 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.

    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.

  • Physical exams and electrocardiograms findings; changes in vital signs, weight and abdominal girth and hematology and urinalysis.

    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.

  • 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.

    The cognitive battery was done at Week 9 or endpoint

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Asenapine

Drug: Asenapine

2

ACTIVE COMPARATOR

Olanzapine

Drug: Olanzapine

Interventions

AsenapineDRUG

Asenapine , 9 weeks

Also known as: Org 5222
1
OlanzapineDRUG

Olanzapine, 9 weeks

2

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with unstable medical conditions or clinically significant laboratory abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord. 2009 Dec;11(8):815-26. doi: 10.1111/j.1399-5618.2009.00749.x. Epub 2009 Oct 14.

    PMID: 19832806DERIVED

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 Design

Study Type
interventional
Phase
phase 3
Allocation
NON 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

August 31, 2005

First Posted

September 2, 2005

Study Start

January 7, 2005

Primary Completion

June 28, 2006

Study Completion

June 28, 2006

Last Updated

August 15, 2024

Record last verified: 2022-02