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CompletedNCT00546403Updated Feb 24, 2009

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

An interventional study of Modafinil and Placebo in Schizophrenia, sponsored by Veterans Medical Research Foundation. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-02-24.

Sponsored by Veterans Medical Research Foundation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study 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.

Read the 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.
02

Conditions studied

  • Schizophrenia

Keywords

  • Excessive Daytime Sleepiness
03

In context

Disorders of Excessive Somnolence

173 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.

This study's enrollment of 26 is below the median of 90 across 133 interventional studies indexed under Disorders of Excessive Somnolence.

Browse Disorders of Excessive Somnolence studies →

Lead sponsor

Veterans Medical Research Foundation is the lead sponsor of 43 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  • Subjects cannot be female.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Adjunctive treatment with placebo

    Drug: Placebo

  • Experimental
    Modafinil

    Treatment with titrated dose of study drug, modafinil.

    Drug: Modafinil

Interventions

  • DrugModafinil

    Adjunctive treatment with titrated dose of modafinil

    Also known as: Provigil

  • DrugPlacebo

    Adjunctive treatment with placebo

06

What researchers measure

Primary outcomes

  1. PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.)

    Time frame: baseline, one month, two months

Secondary outcomes

  1. Neuropsychological Assessments that target cognitive abilities.

    Time frame: baseline, one month, two months

07

Study locations

1 site
  • VA Healthcare System, Department of Psychiatry
    San Diego, California 92161, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00546403
Lead sponsor
Veterans Medical Research Foundation
Collaborators
Cephalon
First posted
Oct 19, 2007
Start date
Feb 2003
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Feb 24, 2009

Study contacts

James B Lohr, MD, PhD
principal investigator · Director, VA Center of Excellence for Stress and Mental Health (CESAMH)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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