Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

NCT00838227 | Withdrawn Phase 2 DMC

• 1 other identifier: 07I/C41-00
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Schizophrenia

Keywords

Schizophrenia; Cognition; Obesity; Sedation

Outcome Measures

Primary Outcomes (1)

• Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB)

  Study withdrawn due to lack of funds.

  8 weeks

Secondary Outcomes (1)

• Sedation and weight changes

  8 weeks

Study Arms (1)

One arm

EXPERIMENTAL

Study withdrawn due to lack of funds.

Drug: modafinil

Interventions

modafinil DRUG

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

Also known as: Provigil

One arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manhattan Psychiatric Center: lead

Related 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. doi: 10.4088/jcp.07r03982. Epub 2008 Nov 18.

  PMID: 19026265 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Obesity

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jean-Pierre Lindenmayer, MD

  Manhattan Psychiatric Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: February 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 14, 2020

Record last verified: 2020-10