Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia

NCT00423943 | Completed Phase 4 Results

• 1 other identifier: 200513585-1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This appears to be responsible for their difficulties in social and occupational functioning. One particular cognitive function that may be important for schizophrenia is called context processing. This refers to the ability to properly use information in the environment to guide thinking and behavior so that it is appropriate to the present circumstance. Problems with this function 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. This cognitive function depends on a region of the brain called the prefrontal cortex, which shows impaired function in schizophrenia as well. Unfortunately, the biochemical aspects of this dysfunction are presently unknown, and it is not clear whether current psychiatric medications can improve this function. A recent FDA-approved medication that may improve this function is modafinil. Studies in animals and healthy adults show that this medication can improve cognitive functions which are related to context processing. We plan to study the effects of modafinil on context processing and the brain activity that underlies this function. We will use functional MRI and electrophysiology to examine the effects of modafinil, both after a single dose and after sustained (4 week) treatment. We predict that when patients receive modafinil they will perform better on cognitive tests and have improved activity in the regions of the brain that are responsible for these cognitive processes.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

cognition; memory

Outcome Measures

Primary Outcomes (3)

• Percent Change in Accuracy on High-control (i.e., Difficult) Condition of Preparing to Overcome Prepotency Task

  Accuracy change on high-control (i.e., difficult) condition of Preparing to Overcome Prepotency (POP) Task. For high-control condition (red-cue), subjects responded in the incongruent direction (eg, for a right-pointing arrow, press the left button, and vice versa). Increased values indicate improved performance.

  Baseline, 4 weeks

• Control-related BOLD Signal Change in Locus Coeruleus

  BOLD signal change on high-control (i.e. difficult) condition versus low-control (i.e. easy) condition, on Preparing to Overcome Prepotency Task, measured by fMRI after 4-week treatment.

  4 weeks

• Gamma Power Change in Count of Clusters

  Power in Gamma frequency range by scalp electrophysiology after single-dose and after 4-week treatment: Count of Clusters (defined as those with statistically-significant Task-Related Increase, i.e. relatively larger value of wavelet coefficient in wavelet analysis of signal) for high-control (i.e. difficult) condition versus Low-control (i.e. easy) condition, in Oscillatory Power in Time-Frequency Spectrogram. Increased values indicate improved function.

  4 weeks

Secondary Outcomes (2)

• Change in Positive Symptoms

  Baseline, 4 weeks

• Change in Negative Symptoms

  Baseline, 4 weeks

Study Arms (2)

D

EXPERIMENTAL

modafinil

Drug: modafinil

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebos

Interventions

modafinil DRUG

200 milligrams daily dose

Also known as: Provigil

D

Placebos DRUG

capsule containing placebo

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 either interferes with experimental measures (e.g. cerebrovascular disease, anemias, etc.) or is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
• significant active substance abuse
• presence of ferromagnetic foreign body or prosthesis
• active pregnancy
• active treatment with medications that have drug interactions with modafinil

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California Los Angeles School of Medicine

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

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
• 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

• Cameron S Carter, MD

  University of California Davis School of Medicine

  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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: September 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 29, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-08

Locations

US (1)