| October 17, 2007 |
| February 20, 2009 |
| February 2003 |
| February 2008 (final data collection date for primary outcome measure) |
| PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.) [ Time Frame: baseline, one month, two months ] [ Designated as safety issue: No ] |
| PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.) [ Time Frame: baseline, one month, two months ] |
| Complete list of historical versions of study NCT00546403 on ClinicalTrials.gov Archive Site |
| Neuropsychological Assessments that target cognitive abilities. [ Time Frame: baseline, one month, two months ] [ Designated as safety issue: No ] |
| Neuropsychological Assessments that target cognitive abilities. [ Time Frame: baseline, one month, two months ] |
| |
| Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia |
| An Eight Week, Double-Blind, Placebo Controlled, Adjunctive Study of the Primary Effects of the Use of Flexible Doses of Modafinil 50mg to 200mg, on the Negative Symptoms, Cognition, and Excessive Daytime Sleepiness in Schizophrenic Patients |
The purpose of this study is to test the effect of modafinil on the negative symptoms, such as blunted affect and social withdrawal, of schizophrenic patients and to determine modafinil's effect on excessive daytime sleepiness. A secondary purpose of the study is to examine the effect of modafinil on cognitive functioning of schizophrenic patients. |
Twenty six male patients with schizophrenia (twelve with Excessive Daytime Sleepiness and twelve without) will be enrolled at the San Diego Veterans Affairs Medical Center. Modafinil has been shown to increase alertness in individuals who are pathologically sleepy (Study C1538a/301/NAIUS).
Subjects will be randomized in a 1:1 ratio, stratified by excessive daytime sleepiness (value of >=9 on the Epworth Sleepiness Scale). Subjects will receive either modafinil or placebo, supplied by the sponsor. The study drug will be taken by mouth once daily in the morning. The titration schedule will be as follows:
- The beginning does will be 50mg for 2 weeks
- The study medication will be increased to 100mg at the week 2 study visit
- The study medication will be increased to 200mg at the week 4 study visit and will continue for the remaining 4 weeks of the study. If subjects are unable to tolerate dosage increases, the dose will be decreased to the previous level.
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| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
| Schizophrenia |
- Drug: Modafinil
- Drug: Placebo
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- Placebo Comparator: Adjunctive treatment with placebo
- Experimental: Treatment with titrated dose of study drug, modafinil.
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| |
| |
| Completed |
| 26 |
| February 2008 |
| February 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
- Subjects cannot be female.
|
| Male |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00546403 |
| James Lohr, MD, Veterans Medical Research Foundation |
| C1538a-633 |
| Veterans Medical Research Foundation |
| Cephalon |
| Principal Investigator: |
James B Lohr, MD, PhD |
Director, VA Center of Excellence for Stress and Mental Health (CESAMH) |
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| Veterans Medical Research Foundation |
| October 2007 |