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

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by:
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00546403
First received: October 17, 2007
Last updated: February 20, 2009
Last verified: October 2007
  Purpose

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 Intervention
Schizophrenia
Drug: Modafinil
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.) [ Time Frame: baseline, one month, two months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychological Assessments that target cognitive abilities. [ Time Frame: baseline, one month, two months ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: February 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546403

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

No publications provided

Responsible Party: James Lohr, MD, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00546403     History of Changes
Other Study ID Numbers: C1538a-633
Study First Received: October 17, 2007
Last Updated: February 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Veterans Medical Research Foundation:
Excessive Daytime Sleepiness

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on October 23, 2014