Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia - Full Text View

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:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Modafinil Armodafinil

U.S. FDA Resources

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:

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.

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

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
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on June 17, 2013