Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)

Organon

Status and phase: Completed; Phase 3

Conditions: Psychosis

Treatments: Drug: Asenapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00281320

P05717

A7501021

Details and patient eligibility

About

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

Enrollment: 122 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elderly subjects with psychosis

Exclusion criteria

• Have an uncontrolled, unstable clinically significant

medical condition.

• Have an established diagnosis of dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups

Asenapine 2-10 mg BID

Experimental group

Description:

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

Treatment:

Drug: Asenapine

Asenapine 5-10mg BID

Experimental group

Description:

Dose titration from 5 mg to 10 mg BID

Treatment:

Drug: Asenapine