Modafinil as an Adjunctive on Cognitive Functioning in Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00314639
• Date of registration: 12/04/2006
• Primary sponsor: Laval University
• Public title: Modafinil as an Adjunctive on Cognitive Functioning in Patients With Schizophrenia
• Scientific title: The Impact of Modafinil as an Adjunctive to a Second Generation Antipsychotic on Cognitive Functioning in Schizophrenia and Schizophrenia Spectrum Psychosis.
• Date of first enrolment: September 2005
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00314639
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Marc-André Roy, MD,MSc,FRCP
• Affiliation: Centre de Recherche Université Laval Robert-Giffard

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia and Schizophrenia Spectrum Psychosis

Intervention(s)

Drug: modafinil

Primary Outcome(s)

Neuropsychological assessments [Time Frame: Pre and post Modafinil and Placebo Phases (Days 0, 28, 42 and 70)]

Secondary Outcome(s)

Psychiatric assessments [Time Frame: 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)]

Secondary ID(s)

4764

Source(s) of Monetary Support

Please refer to primary and secondary sponsors