Modafinil Effects on Cognition in Schizophrenia Patients

NCT00711464 | Completed Phase 4 Results

• 1 other identifier: 200715868-1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This includes many types of cognitive dysfunction, such as in attention, memory and language. These problems may explain why patients with schizophrenia think and act in unusual ways, and often have problems managing aspects of their lives that healthy adults take for granted. Unfortunately, the biochemical aspects of these dysfunctions are presently unknown, and it is not clear whether current psychiatric medications can improve these functions. A recent FDA-approved medication that may improve this function is modafinil. Studies in animals and healthy adults show that this medication can improve many of these cognitive functions. We plan to study the effects of modafinil on these cognitive processes, by giving various doses of this medication to patients before they perform tasks of these cognitive processes. We predict that when patients receive modafinil, they will perform better on a cognitive test, and that these benefits will depend on the dose given.

Conditions

Schizophrenia

Keywords

cognition, pharmacology, memory, attention

Outcome Measures

Primary Outcomes (1)

• Cognitive Performance

  Percent Accuracy on high-control (i.e. difficult) condition on test of cognitive control

  3-5 hours

Secondary Outcomes (2)

• Systolic Blood Pressure

  3-5 hours

• Heart Rate

  3-5 hours

Study Arms (4)

100 mg

EXPERIMENTAL

modafinil 100 milligrams oral dose

Drug: modafinil (M1, M2, M4)

200 mg

EXPERIMENTAL

modafinil 200 mg oral dose

Drug: modafinil (M1, M2, M4)

400 mg

EXPERIMENTAL

modafinil 400 mg oral dose

Drug: modafinil (M1, M2, M4)

Placebo

PLACEBO COMPARATOR

Single oral placebo capsule

Drug: modafinil (M1, M2, M4)

Interventions

modafinil (M1, M2, M4) DRUG

modafinil 100, 200, and 400 mg oral dose

Also known as: Provigil

100 mg; 200 mg; 400 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adults age 18-54
• diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or family history of mental illness
• able to provide informed consent

You may not qualify if:

• history of significant head injury or other neurological illness
• active psychiatric illness requiring significant acute care
• significant intellectual impairment (e.g. standardized full-scale IQ \< 70)
• history of medical illness or treatment that is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
• significant active substance abuse
• active pregnancy
• active treatment with medications that have drug interactions with modafinil

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

University of California, Davis School of Medicine

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Michael Minzenberg, MD
• Organization: University of California, Los Angeles

MMinzenberg@mednet.ucla.edu

(310) 825-7642

Study Officials

• Michael J. Minzenberg, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 8, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 29, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)