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

NCT00546403 | Completed

• 1 other identifier: C1538a-633
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Excessive Daytime Sleepiness

Outcome Measures

Primary Outcomes (1)

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

  baseline, one month, two months

Secondary Outcomes (1)

• Neuropsychological Assessments that target cognitive abilities.

  baseline, one month, two months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Adjunctive treatment with placebo

Drug: Placebo

Modafinil

EXPERIMENTAL

Treatment with titrated dose of study drug, modafinil.

Drug: Modafinil

Interventions

Modafinil DRUG

Adjunctive treatment with titrated dose of modafinil

Also known as: Provigil

Modafinil

Placebo DRUG

Adjunctive treatment with placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):

You may not qualify if:

• Subjects cannot be female.

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• Cephalon: collaborator

Study Sites (1)

VA Healthcare System, Department of Psychiatry

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Schizophrenia; Disorders of Excessive Somnolence

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• James B Lohr, MD, PhD

  Director, VA Center of Excellence for Stress and Mental Health (CESAMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 19, 2007
• Study Start: February 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 24, 2009

Record last verified: 2007-10

Locations

US (1)