Adjunctive Methylphenidate ER in Patients With Schizophrenia to Improve Functional and Cognitive Outcomes
Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
Two of the major features of schizophrenia spectrum illness, negative and cognitive symptoms,
have been associated with poor functional outcome and burden of illness. Given the proposed
role of dopaminergic hypoactivity, augmentation with psychostimulants has been postulated as
one of the potential treatment options for negative and/or cognitive symptoms of
schizophrenia. The major drawback for use of these agents is a potential risk of relapse or
worsening of psychosis through direct or indirect dopamine agonism activity and a great deal
of caution has been called for use of stimulants in individuals with psychosis. However,
preliminary results of earlier studies indicated improvement of negative and cognitive
symptoms with off-label use of adjunctive psychostimulants. The present study aims to assess
off-label use of adjunct psychostimulants in patients with schizophrenia in a tertiary mental
health centre, focusing on efficacy and safety.