SchizophreniaPhase 4NCT00000374
Treatment for First-Episode Schizophrenia
A Phase 4 study testing Olanzapine and Risperidone in people with Schizophrenia, run by Northwell Health at 2 sites in United States.
Trial summary
This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine and Risperidone
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1998to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- First episode schizophrenia, schizophreniform disorder or schizoaffective disorder
Who cannot join
- Prior treatment with antipsychotic medications.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hillside Hospital
Glen Oaks, New York, 11004
Bronx-Lebanon Hospital Center
The Bronx, New York, 10456
About this study
Official title: Preventing Morbidity in First-Episode Schizophrenia
This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.
Read the detailed description
The goal of the study is to prevent morbidity in first-episode schizophrenia using second-generation antipsychotic drugs: olanzapine, risperidone.
Long-term studies of first-episode schizophrenia patients have clearly indicated excellent initial responsiveness of positive psychotic symptoms to treatment with conventional antipsychotic medications. However, in the years immediately following this initial good response, morbidity increases. Relapses, often multiple ones, are the rule and are usually precipitated by medication noncompliance. There is some evidence that the second-generation antipsychotic drugs may have superior efficacy in terms of these outcome domains. However, these newer agents have been studied primarily in chronic and/or treatment-resistant patient samples and there are virtually no long-term studies or studies comparing the new drugs with one another.
First episode patients are randomly assigned to treatment with olanzapine or risperidone for 3 years. Outcome measures for the initial episode include psychopathology (positive, negative, and affective symptoms), side effects, neurocognition (executive function, memory, and attention), social and occupational function and service utilization. The effects on long-term course are measured in terms of frequency and timing of relapses, level of recovery from subsequent episodes and prospectively assessed course of psychopathology, neurocognitive function, social/vocational function, and service utilization.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00320671
- Conditions
- Schizophrenia
- Being tested
- Olanzapine, Risperidone
- Keywords
- Adolescence, Adult, Antipsychotic Agents, Female, Human, Male, olanzapine, Risperidone, Schizophrenia, Antipsychotic Agents -- *therapeutic use, olanzapine -- *therapeutic use, Risperidone -- *therapeutic use, Schizophrenia -- *drug therapy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
The dosage for Olanzapine will be 2.5 mg to 20mg per day. The dose of the Olanzapine will be based on the participant's clinical improvement and side effects.
RisperidoneDrug
The dosage for Risperidone will be 1 mg to 6mg per day. The dose of the Risperidone will be based on the participant's clinical improvement and side effects.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
Measured: 8 consecutive weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startSep 1998
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Zucker Hillside Hospital
- Responsible party
- Principal investigator, Delbert Robinson, National Institute of Mental Health (NIMH)
- Investigators
- Delbert Robinson, MD, Principal investigator, The Zucker Hillside Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000374
- Sponsor's protocol ID
- R01MH060004-01
- Other IDs
- R01MH060004-01, DSIR 83-ATAP
- Status last verified
- Jan 2012
- First submitted
- 2 Nov 1999
- Last updated
- 13 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gallego JA, Robinson DG, Sevy SM, Napolitano B, McCormack J, Lesser ML, Kane JM. Time to treatment response in first-episode schizophrenia: should acute treatment trials last several months? J Clin Psychiatry. 2011 Dec;72(12):1691-6. doi: 10.4088/JCP.10m06349. Epub 2011 Sep 6.
PubMed 21939612
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Morbidity in First-Episode Schizophrenia
- ClinicalTrials.gov ID
- NCT00000374
- Acronym / sponsor ID
- R01MH060004-01
- Conditions
- Schizophrenia
- Keywords
- Adolescence, Adult, Antipsychotic Agents, Female, Human, Male, olanzapine, Risperidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Zucker Hillside Hospital
- Study start
- Sep 1998
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 3 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.
Detailed description
The goal of the study is to prevent morbidity in first-episode schizophrenia using second-generation antipsychotic drugs: olanzapine, risperidone.
Long-term studies of first-episode schizophrenia patients have clearly indicated excellent initial responsiveness of positive psychotic symptoms to treatment with conventional antipsychotic medications. However, in the years immediately following this initial good response, morbidity increases. Relapses, often multiple ones, are the rule and are usually precipitated by medication noncompliance. There is some evidence that the second-generation antipsychotic drugs may have superior efficacy in terms of these outcome domains. However, these newer agents have been studied primarily in chronic and/or treatment-resistant patient samples and there are virtually no long-term studies or studies comparing the new drugs with one another.
First episode patients are randomly assigned to treatment with olanzapine or risperidone for 3 years. Outcome measures for the initial episode include psychopathology (positive, negative, and affective symptoms), side effects, neurocognition (executive function, memory, and attention), social and occupational function and service utilization. The effects on long-term course are measured in terms of frequency and timing of relapses, level of recovery from subsequent episodes and prospectively assessed course of psychopathology, neurocognitive function, social/vocational function, and service utilization.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00320671
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- First episode schizophrenia, schizophreniform disorder or schizoaffective disorder
Key exclusion criteria (1 listed)
- Prior treatment with antipsychotic medications.
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 |
|---|---|---|
| OlanzapineThe dosage for Olanzapine will be 2.5 mg to 20mg per day. The dose of the Olanzapine will be based on the participant's clinical improvement and side effects. | Drug | – |
| RisperidoneThe dosage for Risperidone will be 1 mg to 6mg per day. The dose of the Risperidone will be based on the participant's clinical improvement and side effects. | Drug | – |
Primary outcome
Treatment response
Time frame: 8 consecutive weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
- Derived from this study: PubMed 21939612Gallego JA, Robinson DG, Sevy SM, Napolitano B, McCormack J, Lesser ML, Kane JM. Time to treatment response in first-episode schizophrenia: should acute treatment trials last several months? J Clin Psychiatry. 2011 Dec;72(12):1691-6. doi: 10.4088/JCP.10m06349. Epub 2011 Sep 6.
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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.
Delbert Robinson, MD principal investigator
The Zucker Hillside Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olanzapine and Risperidone in people with Schizophrenia, run by Northwell Health at 2 sites in United States.
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 1 inclusion and 1 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 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment response (time frame: 8 consecutive weeks). 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 NCT00000374, which also lists 1 linked publication.
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 13 Jan 2012.