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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Switching Antipsychotic Medications
- ClinicalTrials.gov ID
- NCT00044655
- Acronym / sponsor ID
- GCO 98-924
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2001
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 5 Sep 2002 (estimated)
- Results
- Posted 5 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stay on baseline medication prescribed | Active comparator | Drug: Risperidone, Drug: Olanzapine, Drug: Ziprasidone, Drug: Quetiapine, Drug: AripiprazoleParticipants 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. |
| Switch per study protocol | Active comparator | Drug: Risperidone, Drug: Olanzapine, Drug: Ziprasidone, Drug: Quetiapine, Drug: AripiprazoleParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisperidoneAlso: Risperdal, Risperdal ConstaAs prescribed by routine prescriber (not dictated by study protocol) | Drug | Stay on baseline medication prescribed, Switch per study protocol |
| OlanzapineAlso: ZyprexaAs prescribed by routine prescriber (not dictated by study protocol) | Drug | Stay on baseline medication prescribed, Switch per study protocol |
| ZiprasidoneAlso: GeodonAs prescribed by routine prescriber (not dictated by study protocol) | Drug | Stay on baseline medication prescribed, Switch per study protocol |
| QuetiapineAlso: SeroquelAs prescribed by routine prescriber (not dictated by study protocol) | Drug | Stay on baseline medication prescribed, Switch per study protocol |
| AripiprazoleAlso: AbilifyAs prescribed by routine prescriber (not dictated by study protocol) | Drug | Stay on baseline medication prescribed, Switch per study protocol |
Primary outcome
Number Who Discontinued Medication Within First 6 Study Months
Time frame: Measured at Six Months
1 secondary outcome
Number of Participants Hospitalized
Time frame: during first 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22480442Covell 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.
- Results publication: PubMed 21536693Essock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M. Essock, PhD study chair
Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risperidone, Olanzapine and Ziprasidone in people with Schizophrenia, run by Icahn School of Medicine at Mount Sinai.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Who Discontinued Medication Within First 6 Study Months (time frame: Measured at Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00044655, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.