Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00838227
• Other study ID #: 07I/C41-00
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2008
• Est. completion date: June 2012

Study information

• Verified date: October 2020
• Source: Manhattan Psychiatric Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This study was withdrawn due to no source of funding to implement the study.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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• modafinil
Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Manhattan Psychiatric Center

References & Publications (1)

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. Epub 2008 Nov 18. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB)	Study withdrawn due to lack of funds.	8 weeks
Secondary	Sedation and weight changes	Study withdrawn due to lack of funds.	8 weeks