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Completed

NCT Number: NCT00044655

Switching Medication to Treat Schizophrenia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Over the past several years, new, "atypical" antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients.

Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or aripiprazole. Participants currently taking a single conventional injectable will begin taking long-acting injectable risperidone (Risperdal Consta). Participants currently taking two antipsychotic medications will begin taking only one of the medications they are currently using. Participants will stay on their assigned treatment for 6 months, after which time the participant's prescribing psychiatrist will advise the participant on which medication should be used. Study participants are interviewed at study start and at follow-up visits for 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Risperidone

Drug

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

Other names: Risperdal, Risperdal Consta

Olanzapine

Drug

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

Other names: Zyprexa

Ziprasidone

Drug

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

Other names: Geodon

Quetiapine

Drug

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

Other names: Seroquel

Aripiprazole

Drug

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

Other names: Abilify

Primary outcomes

  1. Number Who Discontinued Medication Within First 6 Study Months

    Time frame: Measured at Six Months

Secondary outcomes

  1. Number of Participants Hospitalized

    Time frame: during first 6 months

    Number of participants hospitalized for psychiatric reasons

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Effectiveness of Switching Antipsychotic Medications

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Sep 5, 2002
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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