Evaluating the Efficacy of a Late-Life Schizophrenia Integrated Care Pathway to Treat Acute Psychotic Symptoms

NCT02529163 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-08-10

No results posted yet for this study

Summary

As of late Integrated Care Pathways (ICPs) have been shown to improve quality of care in the medical field with special attention given to mental health in particular. One aspect of metal health that has not seen the incorporation of ICPs is in the area of schizophrenia. Late life Schizophrenia (LLS) is defined as suffering from schizophrenia and being 50 years of age or older. The LLS-ICP study will look at the efficacy of an ICP in late life schizophrenia versus treatment as usual (TAU). Participants with LLS and having psychotic symptoms above a predefined threshold will be randomly assigned to a TAU group or an ICP group. The primary outcome measure will be reduction in symptom severity as measured by clinical global impression severity scale (CGI-S) and brief psychiatric rating scale (BPRS). If successful, this study will provide strong evidence to implement LLS-ICP across different inpatient and outpatient settings.

Conditions

Interventions

OTHER

Late-life Schizophrenia ICP

The ICP medication algorithms first trial begins with: * Risperidone titrated to a max dose Failure to Risperidone will lead to a second trial with either: * Quetiapine OR Aripiprazole If subject refuses or if this trial does not work, then offer: * Ziprasidone or Loxapine Failure of 2 anti-psychotic trials results in: * Clozapine trial If subject refuses a Clozapine trial then: * Olanzapine offered titrations occur over 33-36 day period (inpatient) or 12 week period (out patient) with each 0.5 mg titration after the target dose requiring a CGI-E If compliance is an issue then a depot preparation: * Paliperidone * Risperidone * Flupentixol * Aripiprazole Physicians will be prompted for non-pharmacological interventions

OTHER

Treatment as Usual

The TAU group will be offered non-pharmacological interventions such as (but not limited to): * metabolic monitoring * skin hygiene * pain management * nutritional counseling * family counselling * Financial/housing support * Group CBT (Cognitive Behavioral Therapy) Physicians treating this group will use their own discretion as they will not be prompted like the ICP group. Pharmacological interventions contain anti-psychotic medication selected at the discretion of the treating physician provided it fall under the current standard of care such as: * Risperidone * Aripiprazole * Quetiapine * Olanzapine * Paliperidone * Clozapine * Ziprasidone Max dosing and the time to reach the target dose is done at the discretion of the treating physician.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Petal Abdool, MD · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-12-31
Completion
2019-07-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02529163 on ClinicalTrials.gov