SchizophreniaPhase 4NCT00044655
Switching Medication to Treat Schizophrenia
A Phase 4 study testing Risperidone, Olanzapine and Ziprasidone in people with Schizophrenia, run by Icahn School of Medicine at Mount Sinai.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone, Olanzapine and Ziprasidone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Mar 2009
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: Effectiveness of Switching Antipsychotic Medications
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.
Read the detailed description
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.
- Conditions
- Schizophrenia
- Being tested
- Risperidone, Olanzapine, Ziprasidone, Quetiapine, Aripiprazole
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Risperdal, Risperdal Consta
As prescribed by routine prescriber (not dictated by study protocol)
OlanzapineDrug
Also called Zyprexa
As prescribed by routine prescriber (not dictated by study protocol)
ZiprasidoneDrug
Also called Geodon
As prescribed by routine prescriber (not dictated by study protocol)
QuetiapineDrug
Also called Seroquel
As prescribed by routine prescriber (not dictated by study protocol)
AripiprazoleDrug
Also called Abilify
As prescribed by routine prescriber (not dictated by study protocol)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Risperidone; Drug: Olanzapine; Drug: Ziprasidone; Drug: Quetiapine; Drug: 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. Receives: Drug: Risperidone; Drug: Olanzapine; Drug: Ziprasidone; Drug: Quetiapine; Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Who Discontinued Medication Within First 6 Study Months
Measured: Measured at Six Months
Secondary outcomes (1)
Number of Participants Hospitalized
Number of participants hospitalized for psychiatric reasons
Measured: during first 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2002 (estimated)
- Study startJul 2001
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nancy Covell, Icahn School of Medicine at Mount Sinai
- Investigators
- Susan M. Essock, PhD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044655
- Sponsor's protocol ID
- GCO 98-924
- Other IDs
- R01MH059312
- Status last verified
- Apr 2026
- First submitted
- 3 Sep 2002
- Last updated
- 15 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22480442Essock 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.
PubMed 21536693