Apo-Methylphenidate ER arm for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
SchizophreniaApo-Methylphenidate ER - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Schizophrenia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: The PANSS-6 will be completed at all time points (baseline, weeks 1-8, and at follow-up at week 12.

Week 12
Defined as improvement in cognitive functioning
Week 12
Defined as symptom severity
Week 12
Defined as improvement in functioning

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Phase 1-Medication First
51%Appetite Loss
40%Insomnia
33%Irritability
29%Picking at skin, nailbiting
21%Dull, tired, listless
21%Worried/Anxious
19%Tearful, depressed
18%Stomachache
13%Motor Tics
13%Headache
12%Buccal-lingual movements
10%Social Withdrawal
1%Hospitalized
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02039908) in the Phase 1-Medication First ARM group. Side effects include: Appetite Loss with 51%, Insomnia with 40%, Irritability with 33%, Picking at skin, nailbiting with 29%, Dull, tired, listless with 21%.

Trial Design

2 Treatment Groups

Treatment as usual arm
1 of 2
Apo-Methylphenidate ER arm
1 of 2

Active Control

Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Apo-Methylphenidate ER arm · No Placebo Group · Phase 2

Apo-Methylphenidate ER arm
Drug
Experimental Group · 1 Intervention: Apo-Methylphenidate ER · Intervention Types: Drug
Treatment as usual armNoIntervention Group · 1 Intervention: Treatment as usual arm · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: the panss-6 will be completed at all time points (baseline, weeks 1-8, and at follow-up at week 12.

Who is running the clinical trial?

The Royal Ottawa Mental Health CentreLead Sponsor
12 Previous Clinical Trials
1,090 Total Patients Enrolled
5 Trials studying Schizophrenia
276 Patients Enrolled for Schizophrenia
Naista Zhand, M.D.Principal InvestigatorRoyal Ottawa Mental Health Centre

Eligibility Criteria

Age 18 - 55 · All Participants · 4 Total Inclusion Criteria

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