Modafinil as an Adjunctive on Cognitive Functioning in Patients With Schizophrenia
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.