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Home > "E" Clinical Trials Conditions > Effects of Modafinil on Brain Function in Patients with Schizophrenia  Effects of Modafinil on Brain Function in Patients with Schizophrenia
Effects of Modafinil on Brain Function in Patients with Schizophrenia
For Condition: Schizophrenia,Schizoaffective Disorder
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to test the effect of the drug modafinil on brain functioning in individuals with schizophrenia and in healthy volunteers. Drug-induced changes in the catecholaminergic system can enhance some aspects of cognitive functions. Catechol-O-methyl-transferase (COMT) inhibitors can improve working memory and executive functioning, and catecholaminergic agonists such as modafinil can improve delay-dependent working memory. Patients differ in their responses to drugs affecting the catecholaminergic system. These response differences may be related to multiple factors, including gene variation. Polymorphism in the COMT gene accounts for 4% of the variance in performance of working memory tasks, suggesting that COMT genotype may predict response to drugs such as modafinil. Participants in this study will be screened with a physical examination, laboratory tests, and an electrocardiogram (EKG). Women of reproductive potential will have a pregnancy test. The comparison group of healthy volunteers will participate as outpatients; participants with schizophrenia will be admitted to the NIH Clinical Center for up to 12 weeks and will continue to take any necessary medications during this time. Participants will receive either modafinil or placebo (an inactive pill) once a day for the first week of the study. During Week 2, participants will not receive any medication. During Week 3, medications will be crossed over in all participants (those given placebo in week 1 will receive modafinil, and vice versa). Participants will undergo blood collections, psychological tests, and a magnetic resonance imaging (MRI) scan of the brain.
Details: Psychopharmacological modulation of the catecholaminergic system can enhance some aspects of cognitive function. For example, COMT inhibitors can slightly improve working memory/executive function. Similarly, modafinil, a catecholaminergic agonist that increases extracellular dopamine in the prefrontal cortex was also shown to improve delay-dependent working memory. Differences in the response between individuals might be related to a number of factors, including variations in the genes. The recent finding that a polymorphism in the catechol-o-methyl-transferase (COMT) gene, which produces a 4 fold change in enzyme activity, accounts for 4% of the variance in performance of working memory tasks in humans suggest that COMT genotype may predict response to COMT inhibitors or to other agonists that increase catecholaminergic function in the frontal cortex. In the present investigation our goal is to examine, in normal controls and patients with schizophrenia, the effect of modafinil, a drug that increases DA output in the frontal cortex, on cognitive function and brain physiology. We predict that both normal controls and patients with schizophrenia with the val/val genotype will have a significant improvement in working memory compared with individuals possessing other genotypes. Furthermore, in conjunction with other NIMH imaging protocols, we predict that modafinil will produce a similar genotype-dependent effect on the neurophysiological correlates related to working memory assayed with fMRI. The present protocol will provide new insights on the importance of this genetic polymorphism in the regulation of aminergic-controlled cognitive function in normal individuals. Furthermore, this protocol will test whether modafinil offers a new treatment -based on genotype - for cognitive impairment in schizophrenia. An IND waiver was requested to the FDA.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Prior participation under NIH protocol # 95-M-0150, or new normal volunteers. Patients with Schizophrenia or Schizoaffective disorder that meet criteria for NIH protocol # 95-M-0150 will be included. No active Axis I or Axis II diagnosis in normal volunteers. Age range: 18-60 years. EXCLUSION CRITERIA: Subjects with a history of cardiovascular disease, liver disease and other medical illnesses, current active substance abuse, and untreated or uncontrolled hypertension will be excluded. Individuals with persistent tardive dyskinesia or abnormal LFTs will be excluded from the study. An electrocardiogram, blood pressure, pulse rate and metabolic panel including LFTs will be checked on all subjects prior to participation in the study. Schizophrenic patients taking, a COMT inhibitor, any illicit drugs of abuse, or MAO inhibitors will be excluded. Normal control subjects taking any medications affecting brain function will be excluded. Pregnant or breastfeeding women. Women of childbearing potential will undergo a urine pregnancy test the day the study initiates and screened by history for the possibility of pregnancy. Patients with significant history of violence against self or others as established in protocol # 89-M-0160 (Inpatient evaluation of neuropsychiatric patients)
Total Enrollment: 180
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030143; 03-M-0143
Study Start Date: March 26, 2003
Record last reviewed: October 21, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057707
Other Schizoaffective Disorder Studies:
1. Treatment of Schizophrenia Through Internet-Based Psychoeducation
2. Efficacy and safety of two atypical antipsychotics vs. placebo in patients with an acute exacerbation of either schizophrenia or schizoaffective disorder
3. Cognitive - Behavioral Therapy
4. Improving Antipsychotic Adherence Among Patients with Schizophrenia
5. Broad Effectiveness: Study with Aripiprazole
Related Studies:
Other Schizoaffective Disorder Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Effects of Modafinil on Brain Function in Patients with Schizophrenia
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