Trial Evaluating Paliperidone Extended-Release (ER) Tablets Versus Placebo on Sleep in Schizophrenia Patients

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the amelioration of the sleep architecture of patients with schizophrenia and schizophrenia-related insomnia, treated with either 9 mg of extended-release paliperidone ER or placebo, using polysomnography.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Diagnosed with schizophrenia and schizophrenia-related insomnia, no relapse or psychosis for at least 3 months before screening, and considered symptomatically stable

• have apnea/hypopnea score <10 and periodic leg movement score with an arousal index <10

• Weigh >/= 50 kg (>/=110 lbs), with a BMI >/= 18 and
• Agree to adhere to sleep schedule

• Have a sleep history of a minimum of 1.5 hours of wakefulness out of 8 hours in bed.

Exclusion Criteria:

• Current history of suicidal or violent behavior or have exhibited this behavior within the past 6 months

• diagnosis of primary insomnia

• unstable blood pressure

• sleep problems related to general medical conditions, or substance abuse

• diagnosis of or evidence of narcolepsy

• preexisting severe gastrointestinal narrowing.