NCT00493233

Brief Summary

The literature suggests that when a patient is prescribed more than one antipsychotic for at least 30 days, he or she is likely to continue on that combination. In this 12 week study 100 adult patients being treated on more than one antipsychotic medication for at least 30 days will be recruited. In order to control for the natural course of the illness, patients will be randomly assigned to one of two groups: the first group will continue the second medication hidden in a capsule at the same dose, while the second group will be given an inactive capsule (placebo) - the capsules in both group will be identical such that neither the patient nor the treating doctor will be able to identify the group assignment.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2007

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

May 19, 2009

Status Verified

May 1, 2009

Enrollment Period

2.1 years

First QC Date

June 4, 2007

Last Update Submit

May 18, 2009

Conditions

Schizophrenia

Keywords

schizophreniaantipsychoticspolypharmacydouble-blindrandomized

Outcome Measures

Primary Outcomes (2)

  • Brief Psychiatric Rating Scale (BPRS)

    intermittent

  • Clinical Global Impression Scale

    intermittent

Secondary Outcomes (2)

  • Barned Akathisia Scale

    intermittent

  • Simpson-Angus Scale (SAS)

    intermittent

Study Arms (2)

1

EXPERIMENTAL
Drug: 2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine)

2

PLACEBO COMPARATOR
Drug: main antipsychotic medication and placebo

Interventions

2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine)DRUG

Primary antipsychotic medication (olanzapine, oral risperidone, seroquel, clozapine, haldol, perphenazine) will be determined by the treating physician and participants will continue taking the concomitant antipsychotic drug. The dose of the main antipsychotic drug will remain open and flexible at the discretion of the attending physician. The dose of the "second" antipsychotic drug will remain fixed throughout the study period.

1
main antipsychotic medication and placeboDRUG

The "main" antipsychotic drug will be determined by the treating physician. Participants will be allocated to placebo in place of the concomitant antipsychotic drug. The dose of the "main" antipsychotic drug will remain open and flexible at the discretion of the attending physician.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects aged ≥ 18 years
  • Suffering from a primary psychotic disorder (confirmed using the MINI International Neuropsychiatric Interview for DSM-IV (Version 5.0.0)
  • Treated with two antipsychotic drugs for at least 30 days (excluding "prn" or "as needed" antipsychotic prescriptions)

You may not qualify if:

  • A history of treatment with a depot antipsychotic within 6-months of enrollment will be excluded form the study unless the depot antipsychotic is considered the "main" antipsychotic drug in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Publications (1)

  • Borlido C, Remington G, Graff-Guerrero A, Arenovich T, Hazra M, Wong A, Daskalakis ZJ, Mamo DC. Switching from 2 antipsychotics to 1 antipsychotic in schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2016 Jan;77(1):e14-20. doi: 10.4088/JCP.14m09321.

    PMID: 26845273DERIVED

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

RisperidoneClozapineQuetiapine FumarateHaloperidolPerphenazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingDibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsButyrophenonesKetonesPhenothiazines

Study Officials

  • David Mamo, MD, MSc

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2007

First Posted

June 28, 2007

Study Start

November 1, 2006

Primary Completion

December 1, 2008

Last Updated

May 19, 2009

Record last verified: 2009-05

Locations

CA(1)