Recruiting

Aripiprazole vs. Risperidone

Sponsor:

University of British Columbia

Code:

NCT02334904

Conditions

First-Episode Psychosis

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

Aripiprazole

Risperidone

Study Details

Brief summary:

Significant changes in brain morphology are observed in people with first-episode psychosis. Studies have shown that total brain volume and particular brain structures are decreased in people with psychosis disorders. Recent evidence suggests that some atypical antipsychotic drugs can maintain or increase brain volumes. Thus, we plan to use MRI scans to measure changes in brain morphology in subjects recently diagnosed with bipolar or psychosis disorders who are taking the atypical antipsychotic drugs aripiprazole or risperidone. Secondary objectives include taking blood samples for fasting metabolic indices and neuropsychiatric measures for comparisons between drug treatments.

Conditions

First-Episode Psychosis

Bipolar Disorder

Study ID

NCT02334904

Start date

Jul, 2014

Status verified date

May, 2016

Completion date

Jun, 2016

Anticipated

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male or female, aged 12+ years for healthy participants or participants with bipolar disorder; or aged 15+ years for participants with non-affective psychosis.
  • Recent admission to the Vancouver/Richmond Early Psychosis Intervention (EPI) program related to first episode psychosis or first episode bipolar disorder;
  • Participants being treated with an antipsychotic medication principally for psychosis or for bipolar disorder.
  • Participants taking aripiprazole must be taking a dose of at least 10mg/day for the duration of the study.
  • Participants must have received a minimum of 3 months of continuous antipsychotic drug treatment with either aripiprazole or risperidone principally for psychosis or bipolar disorder;
  • Participants may be in- or outpatients.
  • Participants able to give informed consent, or informed consent through legally authorized representative.

Exclusion Criteria:

  • Total life time exposure to the antipsychotic drug aripiprazole vs risperidone for less than 3 months at time of consent.
  • Previously diagnosed with diabetes mellitus, seizure disorders, mental retardation (IQ < 70), or pregnancy (current or within 3 months postpartum)
  • Participants who have been treated/are currently being treated with mood stabilizers (paroxetine, lithium, or valproic acid). Prior or concurrent use of Selective Serotonin Reuptake Inhibitor antidepressants (other than paroxetine) is acceptable..
  • Received antipsychotic polypharmacy (treatment with more than one antipsychotic drug)
  • Participants who are not able to fluently communicate in English.
  • Contraindicated for MRI scan (i.e., has had major surgery in the last 6 months, morbid obesity, claustrophobia, and/or has metal in their bodies from a surgical intervention or working in metalwork, or is unsure if metal is present in their bodies, etc.)

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Aripiprazole

Participants receiving treatment of only aripiprazole, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.

Risperidone

Participants receiving treatment of only risperidone, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.

Controls

Healthy participants who are not taking any antipsychotic medications.

Interventions

Aripiprazole

To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study)

Risperidone

To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).

Primary outcome measure

  • MRI Brain Scans (Composite Measure) [ Time Frame: Day 1 (Visit 1) ]

Central Contacts and Locations

Central contacts

Heidi Boyda, Ph.D

604-612-5025hnboyda@gmail.com

Delrae Fawcett, MSc

604-875-2000delrae.fawcett@ubc.ca

Locations

BC Mental Health & Addictions Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z 4H4

Contacts

Delrae Fawcett, MSc

604-875-2000delrae.fawcett@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Jun 1, 2016

Last verified

May, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2016-06-01.