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Methylphenidate ER for Schizophrenia

Phase 2
Recruiting
Led By Naista Zhand, M.D.
Research Sponsored by The Royal Ottawa Mental Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically stable for the past 8 weeks
Patients with schizophrenia spectrum illness, on any antipsychotic medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the panss-6 will be completed at all time points (baseline, weeks 1-8, and at follow-up at week 12.
Awards & highlights

Study Summary

This trialaims to assess the effects of psychostimulants as an adjunct treatment for schizophrenia, with focus on safety and effectiveness.

Who is the study for?
This trial is for adults aged 18-55 with schizophrenia who have been stable for the past 8 weeks and are on antipsychotic medication. They must be able to communicate in English and not have age-related cognitive impairments, sensitivity to methylphenidate ER, significant heart issues, or a history of substance-induced psychosis.Check my eligibility
What is being tested?
The study tests if adding Apo-Methylphenidate ER (a psychostimulant) can help improve negative symptoms and cognitive functions in patients with schizophrenia without causing a relapse or worsening of their condition.See study design
What are the potential side effects?
Potential side effects may include worsening of psychotic symptoms due to increased dopamine activity from the stimulant. There's also concern about cardiovascular risks like increased heart rate and blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My health condition has been stable for the last 8 weeks.
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I have a schizophrenia spectrum illness and am taking antipsychotic medication.
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I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the panss-6 will be completed at all time points (baseline, weeks 1-8, and at follow-up at week 12.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the panss-6 will be completed at all time points (baseline, weeks 1-8, and at follow-up at week 12. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Defined as improvement in functioning
Secondary outcome measures
Defined as improvement in cognitive functioning
Other outcome measures
Defined as symptom severity

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908
51%
Appetite Loss
40%
Insomnia
33%
Irritability
29%
Picking at skin, nailbiting
21%
Worried/Anxious
21%
Dull, tired, listless
19%
Tearful, depressed
18%
Stomachache
13%
Headache
13%
Motor Tics
12%
Buccal-lingual movements
10%
Social Withdrawal
1%
Hospitalized
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1-Medication First
Phase 1 - Placebo First
Phase 2 - 7-Day Dosing
Phase 2 - 5-Day Dosing

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Apo-Methylphenidate ER armExperimental Treatment1 Intervention
Apo-Methylphenidate ER, 36 mg, oral, once a day, every morning, 4 weeks duration. Methylphenidate ER will be started at 18 mg to test tolerability and will be titrated at day 7 to a dose of 36 mg.
Group II: Treatment as usual armActive Control1 Intervention
Participants in the treatment as usual arm will continue with their current treatment as decided by their treatment team.

Find a Location

Who is running the clinical trial?

The Royal Ottawa Mental Health CentreLead Sponsor
18 Previous Clinical Trials
2,072 Total Patients Enrolled
7 Trials studying Schizophrenia
368 Patients Enrolled for Schizophrenia
Naista Zhand, M.D.Principal InvestigatorRoyal Ottawa Mental Health Centre

Media Library

Apo-Methylphenidate ER arm Clinical Trial Eligibility Overview. Trial Name: NCT05414058 — Phase 2
Schizophrenia Research Study Groups: Apo-Methylphenidate ER arm, Treatment as usual arm
Schizophrenia Clinical Trial 2023: Apo-Methylphenidate ER arm Highlights & Side Effects. Trial Name: NCT05414058 — Phase 2
Apo-Methylphenidate ER arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05414058 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can be considered for admittance into this clinical research?

"This medical trial is recruiting 24 individuals aged 18 - 55 who have schizoaffective disorder. Additionally, participants must be on antipsychotic medication and display cognitive stability for at least 8 weeks prior to joining, as well as fluent in English communication."

Answered by AI

Is this research accommodating participants younger than 80 years old?

"According to the entry requirements of this experiment, all participants must be aged between 18 and 55."

Answered by AI

How risky is Apo-Methylphenidate ER arm to the health of individuals?

"Apo-Methylphenidate ER arm is judged to have a safety rating of 2, as there is only some evidence from Phase 2 trials confirming its security without any efficacy data."

Answered by AI

How many participants are taking part in this exploration?

"That is correct. Clinicaltrials.gov data reveals that this clinical trial, which was first announced on September 9th 2022, is actively recruiting participants. 24 individuals are needed from a single medical centre for the study to move forward."

Answered by AI

Is this research offering recruitment to new participants?

"Clinicaltrials.gov reveals that the recruitment process for this medical trial is in motion, having been initially posted on September 9th 2022 and updated lastly on October 31st 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Adjunctive Methylphenidate ER in Patients With Schizophrenia to Improve Functional and Cognitive Outcomes
2022. "Adjunctive Methylphenidate ER in Patients With Schizophrenia to Improve Functional and Cognitive Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05414058.
~11 spots leftby Sep 2025
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