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Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546403
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : February 24, 2009
Information provided by:
Veterans Medical Research Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Modafinil Drug: Placebo Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2003
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: Placebo
Adjunctive treatment with placebo
Drug: Placebo
Adjunctive treatment with placebo

Experimental: Modafinil
Treatment with titrated dose of study drug, modafinil.
Drug: Modafinil
Adjunctive treatment with titrated dose of modafinil
Other Name: Provigil

Primary Outcome Measures :
  1. PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.) [ Time Frame: baseline, one month, two months ]

Secondary Outcome Measures :
  1. Neuropsychological Assessments that target cognitive abilities. [ Time Frame: baseline, one month, two months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00546403

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United States, California
VA Healthcare System, Department of Psychiatry
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
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Principal Investigator: James B Lohr, MD, PhD Director, VA Center of Excellence for Stress and Mental Health (CESAMH)

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Responsible Party: James Lohr, MD, Veterans Medical Research Foundation Identifier: NCT00546403     History of Changes
Other Study ID Numbers: C1538a-633
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: October 2007

Keywords provided by Veterans Medical Research Foundation:
Excessive Daytime Sleepiness

Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action