NCT00145470

Brief Summary

This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 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

June 2, 2005

Completed
3 months 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
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2007

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2007

Completed
12.5 years until next milestone

Results Posted

Study results publicly available

September 16, 2019

Completed
Last Updated

May 21, 2024

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

September 1, 2005

Results QC Date

April 29, 2019

Last Update Submit

May 8, 2024

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21

    The least squares mean change from baseline in Y-MRS score at day 21 was assessed. The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a last observation carried forward (LOCF) analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.

    Baseline and Day 21

Secondary Outcomes (27)

  • Number of Participants Experiencing an Adverse Event (AE)

    Up to Day 114

  • Number of Participants Discontinuing Study Treatment Due to an AE

    Up to Day 84

  • Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 42

    Baseline and Day 42

  • Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 84

    Baseline and Day 84

  • Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Responder Status

    Up to Day 84

  • +22 more secondary outcomes

Study Arms (2)

Asenapine

EXPERIMENTAL

Participants received asenapine as a fast-dissolving sublingual (SL) tablet, given twice daily (BID). On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.

Drug: Asenapine

Placebo

PLACEBO COMPARATOR

Participants received placebo on Days 1-84 as a fast-dissolving SL tablet, BID.

Drug: Placebo

Interventions

AsenapineDRUG

Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.

Also known as: Org 5222
Asenapine
PlaceboDRUG

Placebo fast dissolving SL tablets, BID

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
  • Treated with lithium or valproic acid

You may not qualify if:

  • Have an unstable medical condition
  • 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
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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 1, 2005

First Posted

September 5, 2005

Study Start

June 2, 2005

Primary Completion

February 28, 2007

Study Completion

March 22, 2007

Last Updated

May 21, 2024

Results First Posted

September 16, 2019

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share