NCT00044655

Brief Summary

This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_4 schizophrenia

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

July 1, 2001

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2002

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

December 5, 2013

Completed
Last Updated

May 15, 2026

Status Verified

April 1, 2026

Enrollment Period

7.7 years

First QC Date

September 3, 2002

Results QC Date

September 27, 2013

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number Who Discontinued Medication Within First 6 Study Months

    Measured at Six Months

Secondary Outcomes (1)

  • Number of Participants Hospitalized

    during first 6 months

Study Arms (2)

Stay on baseline medication prescribed

ACTIVE COMPARATOR

Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.

Drug: RisperidoneDrug: OlanzapineDrug: ZiprasidoneDrug: QuetiapineDrug: Aripiprazole

Switch per study protocol

ACTIVE COMPARATOR

Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.

Drug: RisperidoneDrug: OlanzapineDrug: ZiprasidoneDrug: QuetiapineDrug: Aripiprazole

Interventions

As prescribed by routine prescriber (not dictated by study protocol)

Also known as: Risperdal, Risperdal Consta
Stay on baseline medication prescribedSwitch per study protocol

As prescribed by routine prescriber (not dictated by study protocol)

Also known as: Zyprexa
Stay on baseline medication prescribedSwitch per study protocol

As prescribed by routine prescriber (not dictated by study protocol)

Also known as: Geodon
Stay on baseline medication prescribedSwitch per study protocol

As prescribed by routine prescriber (not dictated by study protocol)

Also known as: Seroquel
Stay on baseline medication prescribedSwitch per study protocol

As prescribed by routine prescriber (not dictated by study protocol)

Also known as: Abilify
Stay on baseline medication prescribedSwitch per study protocol

Eligibility Criteria

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

You may qualify if:

  • SCID diagnosis of schizophrenia or schizoaffective disorder
  • Partially remitted outpatients, defined as persons who have received clear symptomatic benefit from antipsychotic medication but remain symptomatic (due to lack of efficacy or inability to tolerate an efficacious dose) or suffer significant side effects
  • Treatment with antipsychotic medications for at least 2 months
  • Received at least 1 outpatient mental health service every 3 months for the past 6 months

You may not qualify if:

  • Severe symptoms or side effects that indicate the necessity for a medication change
  • Currently taking 3 or more antipsychotic medications for ongoing daily administration (PRN medications and mood stabilizers are allowable)
  • Treatment with clozapine
  • One or more nights spent in a psychiatric hospitalization within the past 3 months
  • Received services from a crisis intervention program within the past 3 months
  • Require placement in a skilled nursing facility as a result of a physical condition or disability
  • Criminal charges pending (once charges clear, the person will be considered)
  • Pregnant or breast feeding
  • Contraindication to any of the medications to which the patient might be assigned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Covell NH, McEvoy JP, Schooler NR, Stroup TS, Jackson CT, Rojas IA, Essock SM; Schizophrenia Trials Network. Effectiveness of switching from long-acting injectable fluphenazine or haloperidol decanoate to long-acting injectable risperidone microspheres: an open-label, randomized controlled trial. J Clin Psychiatry. 2012 May;73(5):669-75. doi: 10.4088/JCP.11m07074. Epub 2012 Mar 6.

  • Essock SM, Schooler NR, Stroup TS, McEvoy JP, Rojas I, Jackson C, Covell NH; Schizophrenia Trials Network. Effectiveness of switching from antipsychotic polypharmacy to monotherapy. Am J Psychiatry. 2011 Jul;168(7):702-8. doi: 10.1176/appi.ajp.2011.10060908. Epub 2011 May 2.

MeSH Terms

Conditions

Schizophrenia

Interventions

RisperidoneOlanzapineziprasidoneQuetiapine FumarateAripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingPiperazinesQuinolonesQuinolines

Results Point of Contact

Title
Nancy H. Covell, Ph.D.
Organization
NYSPI

Study Officials

  • Susan M. Essock, PhD

    Columbia University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, CPI

Study Record Dates

First Submitted

September 3, 2002

First Posted

September 5, 2002

Study Start

July 1, 2001

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 15, 2026

Results First Posted

December 5, 2013

Record last verified: 2026-04