Using methylphenidate to improve cognitive and functional outcomes in schizophrenia
Adjunctive Methylphenidate Extended Release in Patients With Schizophrenia: a Single-centre Fixed Dose Cross-over Open-label Trial to Improve Functional and Cognitive Outcomes
PHASE2 · The Royal Ottawa Mental Health Centre · NCT05414058
This study is testing if adding a medication called methylphenidate can help people with schizophrenia improve their thinking skills and daily functioning while they are already on antipsychotic treatment.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | The Royal Ottawa Mental Health Centre (other) |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05414058 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of adjunctive methylphenidate extended release (ER) in patients with schizophrenia spectrum illness who are stable on antipsychotic medications. It is a single-center, open-label, fixed-dose, controlled cross-over trial conducted at the Royal Ottawa Mental Health Centre. Participants will be randomized to receive either methylphenidate ER or treatment as usual for four weeks, followed by a switch to the alternate treatment for another four weeks. The study aims to measure improvements in functional capacity, cognition, and symptom severity using standardized scales over a total duration of 12 weeks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-55 with schizophrenia spectrum illness who are stable on antipsychotic medications.
Not a fit: Patients with known sensitivity to methylphenidate ER or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new adjunctive treatment option to improve cognitive and functional outcomes for patients with schizophrenia.
How similar studies have performed: Preliminary results from earlier studies have indicated potential improvements with off-label use of adjunctive psychostimulants, suggesting this approach may have merit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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: 1. Uncontrolled hypertension 2. Significant cardiovascular abnormality including history of cardiac interventions, history of myocardial infarction, unstable arrhythmia, congenital heart disease 3. Known family history of premature cardiac death (for males \<45, females \<55) 4. 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
Where this trial is running
Ottawa, Ontario
- Royal Ottawa Mental Health Centre — Ottawa, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Naista Zhand, M.D. — Royal Ottawa Mental Health Centre
- Study coordinator: Carrie Robertson
- Email: carrie.robertson@theroyal.ca
- Phone: 613 722-6521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia Schizoaffective, schizophrenia, methylphenidate, functional outcomes