Study of Asenapine in Elderly Subjects With Psychosis (A7501021) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00281320

Purpose

Asenapine is an investigational drug that may be used in elderly patients with psychosis. This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

Condition	Intervention	Phase
Psychosis	Drug: asenapine	Phase III

MedlinePlus related topics: Psychotic Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety Study
Official Title:	A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.

Further study details as provided by Organon:

Primary Outcome Measures:

Safety in elderly subjects with psychosis. Labs, ecg, vital signs at screen followed by an 8 day inpatient stay, then Days 9 through 42 are outpatient with vital signs, labs, and ecg at several timepoints including Day 42. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic/pharmacodynamic relationship of asenapine in elderly. Serial PK done on Days 3 and 8. Predose PK done on Days 4, 7, 21, and 42. [ Time Frame: Day 3, 8, 21, and 42 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	February 2006
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental asenapine	Drug: asenapine Dose titration from 2 mg to 5 mg to 10 mg then 5 or 10 mg sublingually twice daily for a total of 6-weeks; Dose titration from 5 mg to 10 mg then 5 or 10 mg sublingually twice daily for a total of 6-weeks

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Elderly subjects with psychosis

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281320

Show 62 Study Locations

Sponsors and Collaborators

Organon

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	A7501021, P05717
Study First Received:	January 23, 2006
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00281320
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 15, 2009