NCT00281320

Brief Summary

This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2006

Typical duration for phase_3

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

First Submitted

Initial submission to the registry

January 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 9, 2010

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

January 23, 2006

Results QC Date

August 12, 2010

Last Update Submit

February 7, 2022

Conditions

Psychosis

Outcome Measures

Primary Outcomes (8)

  • Number of Participants Who Experienced an Adverse Event

    Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).

    Up to Day 42 (treatment period)

  • Number of Participants Who Discontinued Because of an Adverse Event

    Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).

    up to 30 days after study medication stop date

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax

    Tmax defined as time to peak concentration.

    Day 4 or 8

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax

    Cmax defined as peak concentration.

    Day 4 or 8

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax

    dn-Cmax is defined as dose normalized peak concentration.

    Day 4 or 8

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin

    Cmin defined as pre-dose concentration.

    Day 4 or 8

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12

    AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.

    Day 4 or 8

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12

    dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.

    Day 4 or 8

Study Arms (2)

Asenapine 2-10 mg BID

EXPERIMENTAL

Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)

Drug: Asenapine

Asenapine 5-10mg BID

EXPERIMENTAL

Dose titration from 5 mg to 10 mg BID

Drug: Asenapine

Interventions

AsenapineDRUG

Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).

Also known as: Saphris
Asenapine 2-10 mg BIDAsenapine 5-10mg BID

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly subjects with psychosis

You may not qualify if:

  • Have an uncontrolled, unstable clinically significant
  • medical condition.
  • Have an established diagnosis of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Dubovsky SL, Frobose C, Phiri P, de Greef R, Panagides J. Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis. Int J Geriatr Psychiatry. 2012 May;27(5):472-82. doi: 10.1002/gps.2737. Epub 2011 Jul 13.

    PMID: 21755540RESULT

MeSH Terms

Conditions

Psychotic Disorders

Interventions

asenapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic 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
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

January 23, 2006

First Posted

January 24, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 9, 2022

Results First Posted

September 9, 2010

Record last verified: 2022-02