NCT00145509

Brief Summary

The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 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

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 16, 2010

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

September 1, 2005

Results QC Date

March 26, 2010

Last Update Submit

February 4, 2022

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (4)

  • Number of Participants Who Experienced an Adverse Event

    Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events).

    up to 52 weeks

  • Number of Participants Who Discontinued Because of an Adverse Event

    Participants who discontinued study medication due to adverse events.

    40 weeks

  • Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score

    The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.

    Baseline and 52 Weeks

  • Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score

    The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms.

    Baseline and 52 Weeks

Study Arms (2)

Asenapine

ACTIVE COMPARATOR

Asenapine

Drug: Asenapine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AsenapineDRUG

Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks

Also known as: Org 5222
Asenapine
PlaceboDRUG

Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

  • Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial

You may not qualify if:

  • Have an unstable medical condition or clinically significant laboratory abnormality.
  • Have a primary diagnosis other than bipolar I disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012 Feb;32(1):46-55. doi: 10.1097/JCP.0b013e31823f872f.

    PMID: 22198448RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

asenapine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

September 1, 2005

First Posted

September 5, 2005

Study Start

August 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 8, 2022

Results First Posted

April 16, 2010

Record last verified: 2022-02