NCT00057707

Brief Summary

This study will evaluate whether modafinil improves cognition in patients with schizophrenia and healthy volunteers. Modafinil is a drug that has been FDA approved for day-time sleepiness and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain ...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2003

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2003

Completed
14.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed
Last Updated

December 9, 2019

Status Verified

June 16, 2017

Enrollment Period

14.2 years

First QC Date

April 5, 2003

Last Update Submit

December 6, 2019

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

CatecholaminesDopaminefMRIWorking MemoryClinical TrialStabilizationInpatientsPlaceboModafinilNormal VolunteersSchizophreniaSchizoaffective DisorderHealthy VolunteerHV

Outcome Measures

Primary Outcomes (1)

  • Genetic differences in working memory testing or fMRI activation

Secondary Outcomes (1)

  • Panss, Ham-A, Blood draws for drug levels and liver enzymes

Interventions

ModafinilDRUG

Placebo 1 week-Wash out 1 week - Drug 1 week (or vice versa)

Functional MRIPROCEDURE
Neuropsychological TestingPROCEDURE

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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: 18-50 years.

You may not qualify if:

  • Subjects with a history of cardiovascular disease, liver disease and other medical illnesses, current active substance abuse or history of substance abuse for more than 5 years, and untreated or uncontrolled hypertension will be excluded. Individuals with persistent tardive dyskinesia 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, buproprion, stimulants, other cognitive enhancers or 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Aguirre JA, Cintra A, Hillion J, Narvaez JA, Jansson A, Antonelli T, Ferraro L, Rambert FA, Fuxe K. A stereological study on the neuroprotective actions of acute modafinil treatment on 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-induced nigral lesions of the male black mouse. Neurosci Lett. 1999 Nov 19;275(3):215-8. doi: 10.1016/s0304-3940(99)00706-5.

    PMID: 10580713BACKGROUND

  • Aksoy S, Klener J, Weinshilboum RM. Catechol O-methyltransferase pharmacogenetics: photoaffinity labelling and western blot analysis of human liver samples. Pharmacogenetics. 1993 Apr;3(2):116-22. doi: 10.1097/00008571-199304000-00008.

    PMID: 8518836BACKGROUND

  • Andreasen NC, Arndt S, Cizadlo T, O'Leary DS, Watkins GL, Ponto LL, Hichwa RD. Sample size and statistical power in [15O]H2O studies of human cognition. J Cereb Blood Flow Metab. 1996 Sep;16(5):804-16. doi: 10.1097/00004647-199609000-00005.

    PMID: 8784225BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

ModafinilNeuropsychological Tests

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Jose A Apud, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 5, 2003

First Posted

April 7, 2003

Study Start

March 26, 2003

Primary Completion

June 16, 2017

Study Completion

June 16, 2017

Last Updated

December 9, 2019

Record last verified: 2017-06-16

Locations

US(1)