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NCT05414058CompletedPhase 2

Adjunctive Methylphenidate ER in Patients With Schizophrenia to Improve Functional and Cognitive Outcomes

Adjunctive Methylphenidate Extended Release in Patients With Schizophrenia: a Single-centre Fixed Dose Cross-over Open-label Trial to Improve Functional and Cognitive Outcomes

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
35 (actual)
First submitted
7 Jun 2022
Start date
9 Sept 2022
Primary completion date
21 Aug 2024
Lead sponsor
The Royal Ottawa Mental Health Centre
NCT number
NCT05414058

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 35
  • From 9 Sept 2022 to the primary completion date, 21 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have had treatment with ECT in the past 6 months
  • Have a history of previous safety concerns directly driven by positive symptoms (e.g history of suicide attempt as directed by auditory hallucinations)

Other illness

  • 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
  • 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.)

Other

  • Have known sensitivity to methylphenidate ER, as documented in the electronic medical record OR, as reported by the patient AND verified by pharmacy
  • 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 current active suicidality

Who the study is looking for

  • 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

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Royal Ottawa Mental Health Centre
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.