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Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia
This study has been completed.
Study NCT00546403   Information provided by Veterans Medical Research Foundation
First Received: October 17, 2007   Last Updated: February 20, 2009   History of Changes

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:

  1. The beginning does will be 50mg for 2 weeks
  2. The study medication will be increased to 100mg at the week 2 study visit
  3. 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.
 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Schizophrenia
  • Drug: Modafinil
  • Drug: Placebo
  • Placebo Comparator: Adjunctive treatment with placebo
  • Experimental: Treatment with titrated dose of study drug, modafinil.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
26
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must be able to communicate and give voluntary informed consent
  • Subjects must be of the male gender
  • Between the ages of 18 to 65 years.
  • A diagnosis of Schizophrenia or Schizoaffective disorder as determined by DSM-IV criteria.
  • Not conservatorized
  • A negative symptom score on the PANSS of >= 20 and an MMSE score of >24
  • No clinical evidence of a current unstable medical illness
  • No current clinical evidence or past history of cerebral neurological impairment (including strokes, tumors or trauma leading to loss of consciousness)
  • No history of drug or alcohol dependence in the past 2 years
  • No evidence of drug or alcohol abuse in the past year, as determined by the DSM-IV criteria.
  • No diagnosis of Narcolepsy as determined by DSM-IV criteria
  • Must have an approved contact person for the duration of the study
  • May be on a stable dose of SSRI for depressive symptoms
  • No history of aggression
  • No uncontrolled hypertension, as defined below (subjects cannot have any of the following):

    1. a new diagnosis of hypertension, or
    2. a change in antihypertensive medications in the past 30 days, or
    3. acute hypertension (systolic>160mmHg, diastolic>100mmHg)
  • Maybe on a stable dose of a benzodiazepine
  • The following medications will not be allowed during the study- methylphenidate, amphetamines, pemoline, zolpidem, MAO inhibitors, anticoagulant, TCA's, or barbiturates.
  • Be on a stable does of an atypical neuroleptic
  • May be on a stable does of an anticonvulsant for mood stabilization

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)
Veterans Medical Research Foundation
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP