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

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ClinicalTrials.gov Identifier: NCT00546403
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : February 24, 2009
Sponsor:
Collaborator:
Cephalon
Information provided by:
Veterans Medical Research Foundation

Tracking Information
First Submitted Date  ICMJE October 17, 2007
First Posted Date  ICMJE October 19, 2007
Last Update Posted Date February 24, 2009
Study Start Date  ICMJE February 2003
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2007)
PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.) [ Time Frame: baseline, one month, two months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00546403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2007)
Neuropsychological Assessments that target cognitive abilities. [ Time Frame: baseline, one month, two months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Modafinil
    Adjunctive treatment with titrated dose of modafinil
    Other Name: Provigil
  • Drug: Placebo
    Adjunctive treatment with placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Adjunctive treatment with placebo
    Intervention: Drug: Placebo
  • Experimental: Modafinil
    Treatment with titrated dose of study drug, modafinil.
    Intervention: Drug: Modafinil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2007)
26
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00546403
Other Study ID Numbers  ICMJE C1538a-633
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Lohr, MD, Veterans Medical Research Foundation
Study Sponsor  ICMJE Veterans Medical Research Foundation
Collaborators  ICMJE Cephalon
Investigators  ICMJE
Principal Investigator: James B Lohr, MD, PhD Director, VA Center of Excellence for Stress and Mental Health (CESAMH)
PRS Account Veterans Medical Research Foundation
Verification Date October 2007

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