Back to resultsModafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modafinil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Excessive Daytime Sleepiness
Eligibility 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):
- a new diagnosis of hypertension, or
- a change in antihypertensive medications in the past 30 days, or
- 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.
Sites / Locations
- VA Healthcare System, Department of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Modafinil
Arm Description
Adjunctive treatment with placebo
Treatment with titrated dose of study drug, modafinil.
Outcomes
Primary Outcome Measures
PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.)
Secondary Outcome Measures
Neuropsychological Assessments that target cognitive abilities.
Full Information
NCT ID
NCT00546403
First Posted
October 17, 2007
Last Updated
February 20, 2009
Sponsor
Veterans Medical Research Foundation
Collaborators
Cephalon
1. Study Identification
Unique Protocol Identification Number
NCT00546403
Brief Title
Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia
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 Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
Cephalon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
The beginning does will be 50mg for 2 weeks
The study medication will be increased to 100mg at the week 2 study visit
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Excessive Daytime Sleepiness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Adjunctive treatment with placebo
Arm Title
Modafinil
Arm Type
Experimental
Arm Description
Treatment with titrated dose of study drug, modafinil.
Intervention Type
Drug
Intervention Name(s)
Modafinil
Other Intervention Name(s)
Provigil
Intervention Description
Adjunctive treatment with titrated dose of modafinil
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Adjunctive treatment with placebo
Primary Outcome Measure Information:
Title
PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.)
Time Frame
baseline, one month, two months
Secondary Outcome Measure Information:
Title
Neuropsychological Assessments that target cognitive abilities.
Time Frame
baseline, one month, two months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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):
a new diagnosis of hypertension, or
a change in antihypertensive medications in the past 30 days, or
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B Lohr, MD, PhD
Organizational Affiliation
Director, VA Center of Excellence for Stress and Mental Health (CESAMH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Healthcare System, Department of Psychiatry
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia
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