Status:
COMPLETED
Trial Evaluating Paliperidone Extended-Release (ER) Tablets Versus Placebo on Sleep in Schizophrenia Patients
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Insomnia
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief 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-re...
Detailed Description
Paliperidone is the major active substance produced by the metabolism of risperidone in the body. In patients with schizophrenia, risperidone has been shown to improve the quality of sleep. Therefore ...
Eligibility Criteria
Inclusion
- 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 \</= 35 kg/m2, inclusive
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00105326
Start Date
February 1 2005
End Date
August 1 2005
Last Update
May 24 2010
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