Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Manhattan Psychiatric Center

Status and phase

Withdrawn

Phase 2

Conditions

Schizophrenia

Treatments

Drug: modafinil

Study type

Interventional

Funder types

Other

Identifiers

NCT00838227

07I/C41-00

Details and patient eligibility

About

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

Full description

This study was withdrawn due to no source of funding to implement the study.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

Sex

All

Ages

18 to 64 years old

Volunteers

No 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
History of an eating disorder
Ready for discharge within the following 8 weeks.