Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

NCT ID: NCT00838227

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2012-06-30

Brief 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This study was withdrawn due to no source of funding to implement the study.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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One arm

Study withdrawn due to lack of funds.

Group Type: EXPERIMENTAL

modafinil

Intervention Type: DRUG

Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen

Interventions

modafinil

Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen

Intervention Type: DRUG

Other Intervention Names

Provigil

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manhattan Psychiatric Center

OTHER

Sponsor Role: lead

Responsible Party

Jean-Pierre Lindenmayer

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Pierre Lindenmayer, MD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Psychiatric Center

References

Saavedra-Velez C, Yusim A, Anbarasan D, Lindenmayer JP. Modafinil as an adjunctive treatment of sedation, negative symptoms, and cognition in schizophrenia: a critical review. J Clin Psychiatry. 2009 Jan;70(1):104-12. doi: 10.4088/jcp.07r03982. Epub 2008 Nov 18.

Reference Type: BACKGROUND

PMID: 19026265 (View on PubMed)

Other Identifiers

07I/C41-00

Identifier Type: -

Identifier Source: org_study_id