SchizophreniaNCT02775864
Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia
An observational study of Schizophrenia and Schizoaffective Disorder, run by New York State Psychiatric Institute.
Trial summary
The study is a retrospective cohort study of adults with schizophrenia that will compare outcomes of new users of alternative psychotropic medication strategies using 10 years of Medicaid data. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Antipsychotic, Antidepressant and Benzodiazepine
- How many people
- 81,921 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jun 2018
- Phase
- Observational
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults diagnosed with schizophrenia who are taking only a single antipsychotic medication who initiate treatment with an additional psychotropic medication.
Who may be able to join
- The data source will be national (45-state) Medicaid Analytic Extracts data (2001-2010). The cohort will consist of adults who are 18 to 64 years old and diagnosed with schizophrenia who initiate a new psychotropic medication after a period of stable antipsychotic treatment.
- Schizophrenia will be defined as ≥2 outpatient claims or ≥1 inpatient claim for schizophrenia [ICD-9-CM: 295] during 365 days of consecutive Medicaid enrollment immediately prior to the index date. Stable antipsychotic monotherapy will be defined by filled prescriptions for only one second-generation antipsychotic, and no other psychotropics, for ≥ 90 days immediately preceding the start of the index medication (t0). After the ≥90 days of stable treatment with a single second-generation antipsychotic, study patients will have had a change in therapy defined as (1) addition of a second antipsychotic or (2) addition of a different psychotropic drug class (antidepressant, mood stabilizer, or benzodiazepine). To ensure the patients are in active treatment there must be an active supply of antipsychotic medication on t0.
Who cannot join
- Medicare recipients
- Patients receiving clozapine
About this study
The study is a retrospective cohort study of adults with schizophrenia that will compare outcomes of new users of alternative psychotropic medication strategies using 10 years of Medicaid data. The primary comparative effectiveness analyses will focus on subgroups of patients with schizophrenia facing common clinical situations.
Read the detailed description
This retrospective cohort study will use data from national (45-state) Medicaid Analytic Extracts data (2001-2010). The cohort will consist of adults who are 18 to 64 years old and diagnosed with schizophrenia who initiate a new psychotropic medication after a period of stable antipsychotic treatment.
The eligibility criteria select a cohort of individuals diagnosed with schizophrenia, have received antipsychotic monotherapy prior to the index date, and are still experiencing problems for which a new psychotropic medication strategy was initiated. A 1-year period of eligibility prior to follow-up initiation ensures sufficient time to collect service use related covariates to characterize cohort members.
Five clinical subgroups will be defined based on the presence of psychiatric diagnoses during the 30 days prior to and inclusive of the treatment change under study (index date) and who have this same diagnostic code from more than one provider to increase the validity of the diagnostic groups. The subgroups will be defined by codes to capture 1) uncomplicated schizophrenia; 2) schizoaffective disorder; 3) depression; 4) mania; and 5) anxiety. These subgroups are defined to reflect the reason for the change in treatment.
Pharmacological treatment options for patients with schizophrenia who are nonresponsive to antipsychotic monotherapy will include (1) initiation of a second antipsychotic, (2) initiation of an antidepressant, (3) initiation of a mood stabilizer and (4) initiation of a benzodiazepine.
The primary effectiveness outcome will be time to psychiatric hospitalization. Secondary measures include time to index treatment discontinuation, time to introduction of another psychotropic medication, psychiatric emergency department visits, all-cause hospitalization, and death.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Antipsychotic, Antidepressant, Benzodiazepine, Mood stabilizer
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntipsychoticDrug
New initiation of any antipsychotic medication
AntidepressantDrug
New initiation of any antidepressant medications
BenzodiazepineDrug
New initiation of any benzodiazepine
Mood stabilizerDrug
New initiation of lithium or any mood stabilizing anti-epileptic drug
| Study group | Role | What they receive |
|---|---|---|
| Antipsychotic | Individuals initiating treatment with an antipsychotic medication Receives: Drug: Antipsychotic | |
| Antidepressant | Individuals initiating treatment with an antidepressant medication Receives: Drug: Antidepressant | |
| Benzodiazepine | Individuals initiating treatment with a benzodiazepine Receives: Drug: Benzodiazepine | |
| Mood stabilizer | Individuals initiating treatment with a mood stabilizer Receives: Drug: Mood stabilizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric Hospitalization
Number of participants hospitalized for a mental health reason
Measured: One year
Secondary outcomes (2)
Emergency Department Visit for Mental Health Reason
Number of Participants with an Emergency Department visit for mental health reason
Measured: One year
Death
Participants who died
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJul 2015
- Primary completionApr 2018
- Study completionJun 2018
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81,921 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Scott Stroup, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775864
- Sponsor's protocol ID
- 7226
- Status last verified
- Apr 2024
- First submitted
- 13 May 2016
- Last updated
- 1 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia
- ClinicalTrials.gov ID
- NCT02775864
- Acronym / sponsor ID
- 7226
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81,921 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Rutgers University, Patient-Centered Outcomes Research Institute
- Study start
- Jul 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Posted 7 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a retrospective cohort study of adults with schizophrenia that will compare outcomes of new users of alternative psychotropic medication strategies using 10 years of Medicaid data. The primary comparative effectiveness analyses will focus on subgroups of patients with schizophrenia facing common clinical situations.
Detailed description
This retrospective cohort study will use data from national (45-state) Medicaid Analytic Extracts data (2001-2010). The cohort will consist of adults who are 18 to 64 years old and diagnosed with schizophrenia who initiate a new psychotropic medication after a period of stable antipsychotic treatment.
The eligibility criteria select a cohort of individuals diagnosed with schizophrenia, have received antipsychotic monotherapy prior to the index date, and are still experiencing problems for which a new psychotropic medication strategy was initiated. A 1-year period of eligibility prior to follow-up initiation ensures sufficient time to collect service use related covariates to characterize cohort members.
Five clinical subgroups will be defined based on the presence of psychiatric diagnoses during the 30 days prior to and inclusive of the treatment change under study (index date) and who have this same diagnostic code from more than one provider to increase the validity of the diagnostic groups. The subgroups will be defined by codes to capture 1) uncomplicated schizophrenia; 2) schizoaffective disorder; 3) depression; 4) mania; and 5) anxiety. These subgroups are defined to reflect the reason for the change in treatment.
Pharmacological treatment options for patients with schizophrenia who are nonresponsive to antipsychotic monotherapy will include (1) initiation of a second antipsychotic, (2) initiation of an antidepressant, (3) initiation of a mood stabilizer and (4) initiation of a benzodiazepine.
The primary effectiveness outcome will be time to psychiatric hospitalization. Secondary measures include time to index treatment discontinuation, time to introduction of another psychotropic medication, psychiatric emergency department visits, all-cause hospitalization, and death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Antipsychotic | – | Drug: AntipsychoticIndividuals initiating treatment with an antipsychotic medication |
| Antidepressant | – | Drug: AntidepressantIndividuals initiating treatment with an antidepressant medication |
| Benzodiazepine | – | Drug: BenzodiazepineIndividuals initiating treatment with a benzodiazepine |
| Mood stabilizer | – | Drug: Mood stabilizerIndividuals initiating treatment with a mood stabilizer |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults diagnosed with schizophrenia who are taking only a single antipsychotic medication who initiate treatment with an additional psychotropic medication.
Key inclusion criteria (2 listed)
- The data source will be national (45-state) Medicaid Analytic Extracts data (2001-2010). The cohort will consist of adults who are 18 to 64 years old and diagnosed with schizophrenia who initiate a new psychotropic medication after a period of stable antipsychotic treatment.
Key exclusion criteria (2 listed)
- Medicare recipients
- Patients receiving clozapine
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 |
|---|---|---|
| AntipsychoticNew initiation of any antipsychotic medication | Drug | Antipsychotic |
| AntidepressantNew initiation of any antidepressant medications | Drug | Antidepressant |
| BenzodiazepineNew initiation of any benzodiazepine | Drug | Benzodiazepine |
| Mood stabilizerNew initiation of lithium or any mood stabilizing anti-epileptic drug | Drug | Mood stabilizer |
Primary outcome
Psychiatric Hospitalization
Time frame: One year
Number of participants hospitalized for a mental health reason
2 secondary outcomes
Emergency Department Visit for Mental Health Reason
Time frame: One year
Death
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by New York State Psychiatric Institute.
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 2 inclusion and 2 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 1 May 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2019). 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?
Psychiatric Hospitalization (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2024.