- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00314639
Modafinil as an Adjunctive on Cognitive Functioning in Patients With Schizophrenia
February 11, 2009 updated by: Laval University
The Impact of Modafinil as an Adjunctive to a Second Generation Antipsychotic on Cognitive Functioning in Schizophrenia and Schizophrenia Spectrum Psychosis.
Patients suffering from schizophrenia and schizophrenia spectrum psychosis frequently experience cognitive impairments.
Such deficits may affect memory, attention and executive function processes.
Many studies have shown that cognitive impairments predict daily functioning.
Improvement of these difficulties represents a major component of recovery in such population.
Second generation antipsychotics, now first line intervention, have been shown to improve cognitive processes compared to first generation agents.
However, more subtle cognitive impairments may still remain.
In fact, cognitive impairments is one of the most frequent subjective complaints from patients and their family, even though antipsychotic treatment has been optimized.
Very few options are available to clinicians to try to improve such persistent cognitive difficulties.
First, cognitive remediation techniques have shown some effectiveness but results are sparse and come from a very small number of studies.
It is also not clear if cognitive improvement obtained from such techniques would apply to daily functioning and can be generalized.A second possible intervention would be to add a pharmacological agent able to improve cognition.
Modafinil (Alertec) is officially indicated for improving wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.
Some empirical data and clinical observations suggest that modafinil could improve alertness and/or cognitive functioning without exacerbating psychotic features in persons with schizophrenia and psychotic disease in the spectrum of schizophrenia.
This study aims to (a) assess the effect on cognitive functioning of modafinil as an adjunctive to a second generation antipsychotic in a prospective cohort of thirty patients suffering from schizophrenia and psychosis in the spectrum of schizophrenia.
This study will also (b) evaluate the impacts of the addition of modafinil on side effects, psychopathology symptoms and other health parameters (such as weight, metabolic profile, etc.).
Our principal hypothesis is that significant improvements will be observed on attention processes without any exacerbation of psychotic symptoms or major emerging side effects.
This cross-over placebo-controlled prospective study will include patients with schizophrenia or psychosis in the schizophrenia spectrum according to DSM IV definition, men or women aged over 18 years old, with no item score equal or over 5 at PANSS positive symptoms subscale.
At enrollment, all patients will have to experience significant cognitive difficulties with scores equal or lower than Z=-1.00 at Color trail test, Mesulam and Weintraub Cancellation Test, Stroop test or Continuous Performance Test-II.
Patients will be exposed to 100mg daily of Placebo or Modafinil for 2 weeks than to 200mg daily for the two following weeks.
A two weeks wash out period will then take place before the same sequence will be start again.
Patient will thus be exposed one month to placebo and one month to modafinil or conversely, in a random fashion.Assessments will include neurocognitive standardized battery, psychopathological tools (PANSS, CGI, SOFAS, SDS), side effects (UKU, ESRS, DAI), vital signs, anthropometric and metabolic profile.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Quebec, Canada, G1J 2G3
- Centre hospitalier Robert-Giffard
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- To have a diagnosis of schizophrenia or schizophrenia spectrum psychosis (schizophreniform, schizoaffective, delusional trouble, brief psychosis), as defined in Diagnostic and statistical manual of mental disorders ([DSM-IV], American Psychiatric Association [APA], 1995);
- To be 18 years old or more;
- Psychotic symptoms must be stabilized with a second generation antipsychotic for at least 4 weeks i.e. no item on Positive And Negative Syndrome Scale ([PANSS], Kay, Opler, & Fiszbein, 1987) positive subscale equal or superior to a score of 5.
- Neurocognitive impairments are observed on attention measures. Participants will merit one or more result equal or lower to Z = -1,00 in at least one attention task.(Color trail test part A, MWCT, Stroop test, CPT-II).
Exclusion Criteria:
- To have a diagnosis of mental retardation (APA, 1994), or medical affection other than schizophrenia or schizophrenia spectrum psychosis, or neurological troubles that can lead to cognitive impairments (ex : temporal epilepsy);
- To have a current diagnosis of panic disorder (DSM-IV);
- To manifest an important suicidal potential according to the psychiatrist clinical judgment;
- To suffer from unstable hypertension, cardiac arrhythmia or any other cardiac disorders;
- To take medications, drugs and/or natural products that have a stimulant effect on the CNS (e.g., cocaine, methylphenidate); and
- To be a pregnant woman, who breast-feed, or a woman who do not use an effective contraceptive (abstinence is considered like an effective method).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neuropsychological assessments
Time Frame: Pre and post Modafinil and Placebo Phases (Days 0, 28, 42 and 70)
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Pre and post Modafinil and Placebo Phases (Days 0, 28, 42 and 70)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Psychiatric assessments
Time Frame: Pre, middle, & post Modafinil and Placebo phases (Days 0, 14, 28, 42, 56, 70)
|
Pre, middle, & post Modafinil and Placebo phases (Days 0, 14, 28, 42, 56, 70)
|
Safety assessments
Time Frame: Pre, middle, & post Modafinil and Placebo phases (Days 0, 14, 28, 42, 56, 70)
|
Pre, middle, & post Modafinil and Placebo phases (Days 0, 14, 28, 42, 56, 70)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc-André Roy, MD,MSc,FRCP, Centre de Recherche Université Laval Robert-Giffard
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
June 1, 2008
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
April 12, 2006
First Submitted That Met QC Criteria
April 12, 2006
First Posted (Estimate)
April 14, 2006
Study Record Updates
Last Update Posted (Estimate)
February 12, 2009
Last Update Submitted That Met QC Criteria
February 11, 2009
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Psychotic Disorders
- Mental Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- 4764
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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