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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
      • Quebec, Canada, G1J 2G3
        • Centre hospitalier Robert-Giffard

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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);
  2. To be 18 years old or more;
  3. 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.
  4. 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:

  1. 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);
  2. To have a current diagnosis of panic disorder (DSM-IV);
  3. To manifest an important suicidal potential according to the psychiatrist clinical judgment;
  4. To suffer from unstable hypertension, cardiac arrhythmia or any other cardiac disorders;
  5. To take medications, drugs and/or natural products that have a stimulant effect on the CNS (e.g., cocaine, methylphenidate); and
  6. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Neuropsychological assessments
Time Frame: Pre and post Modafinil and Placebo Phases (Days 0, 28, 42 and 70)
Pre and post Modafinil and Placebo Phases (Days 0, 28, 42 and 70)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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