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Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder | Clinical Trials | Clareo Health

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Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study

NCT00838227•Manhattan Psychiatric Center

Summary

This is an open label 8-week trial of modafinil up to 400 mg daily added to a stable antipsychotic regimen to evaluate the effect modafinil on cognition, sedation, and weight in patients with chronic schizophrenia. We hypothesize that modafinil, a wake-promoting agent, will lead to improved cognition, increased wakefulness, and decreased weight in patients with schizophrenia who are on stable antipsychotic regimens

Detailed Description

This study was withdrawn due to no source of funding to implement the study. No participants were enrolled for this study.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnostic and Statistical Manual-IV diagnosis of schizophrenia (all subtypes), illness duration greater than three years
•Auditory and visual acuity adequate to complete cognitive tests
•Stable dose of antipsychotics for at least 2 weeks prior to entry
•Good physical health determined by complete physical examination, laboratory tests, and EKG
•Capacity and willingness to give written informed consent.

Exclusion Criteria

•Inability to read or speak English
•Documented disease of the central nervous system
•History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
•Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions;
•HIV positive
•Patients on antidepressants, including monoamine oxidase inhibitors
•Uncontrolled hypertension
•Pregnancy
•Patients with a current diagnosis of substance dependence
•Significant history of violence
+2 more criteria

Key Dates

Start Date

February 1, 2008

Primary Completion Date

January 1, 2012

Completion Date

June 1, 2012

Last Updated

October 14, 2020

Conditions

Schizophrenia

Interventions

modafinil

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques

Brain Stimulation to the Hippocampus in Schizophrenia