Status:
COMPLETED
Adjunctive Methylphenidate ER in Patients With Schizophrenia to Improve Functional and Cognitive Outcomes
Lead Sponsor:
The Royal Ottawa Mental Health Centre
Conditions:
Schizophrenia Schizoaffective
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 dopami...
Detailed Description
This project focuses on assessing efficacy of off-label use of adjunctive methylphenidate ER 36 mg among 24 stable patients with schizophrenia spectrum illness. This is a single centre study at the Ro...
Eligibility Criteria
Inclusion
- Adult between the ages of 18-55; we chose an upper age limit of 55 years to exclude patients with potential age-related cognitive impairments which usually occur about a decade earlier in patients with schizophrenia
- Inpatient or outpatient with schizophrenia spectrum illness, on any antipsychotic medication
- Clinically stable for the past 4 weeks
- Able to communicate in English
Exclusion
- Have known sensitivity to methylphenidate ER, as documented in the electronic medical record OR, as reported by the patient AND verified by pharmacy
- Have had treatment with ECT in the past 6 months
- Have a history of traumatic brain injury
- Have a contraindication to psychostimulants including:
- Uncontrolled hypertension
- Significant cardiovascular abnormality including history of cardiac interventions, history of myocardial infarction, unstable arrhythmia, congenital heart disease
- Known family history of premature cardiac death (for males \<45, females \<55)
- Known history of glaucoma
- Are currently pregnant or planning to become pregnant- a rapid urine pregnancy test will be done for female participants, and a refusal to take the test or a positive test will exclude the participant
- Have a diagnosis of substance induced psychosis
- Have any of the following diagnoses: neurodevelopmental delay, intellectual disability or neurocognitive disorder (dementia)
- Have a diagnosis of another currently significant and unstable psychiatric condition (i.e. depressive episode, active substance use disorder, etc.)
- Have a history of previous safety concerns directly driven by positive symptoms (e.g history of suicide attempt as directed by auditory hallucinations)
- Have current active suicidality
Key Trial Info
Start Date :
September 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05414058
Start Date
September 9 2022
End Date
September 18 2024
Last Update
December 12 2025
Active Locations (1)
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1
Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada, K1Z 7K4