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Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02775864
Recruitment Status : Completed
First Posted : May 18, 2016
Results First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
Rutgers University
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Scott Stroup, Columbia University

Brief 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. The primary comparative effectiveness analyses will focus on subgroups of patients with schizophrenia facing common clinical situations.

Condition or disease Intervention/treatment
Schizophrenia Schizoaffective Disorder Drug: Antipsychotic Drug: Antidepressant Drug: Benzodiazepine Drug: Mood stabilizer

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.

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Study Type : Observational
Actual Enrollment : 81921 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia
Study Start Date : July 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
Antipsychotic
Individuals initiating treatment with an antipsychotic medication
Drug: Antipsychotic
New initiation of any antipsychotic medication

Antidepressant
Individuals initiating treatment with an antidepressant medication
Drug: Antidepressant
New initiation of any antidepressant medications

Benzodiazepine
Individuals initiating treatment with a benzodiazepine
Drug: Benzodiazepine
New initiation of any benzodiazepine

Mood stabilizer
Individuals initiating treatment with a mood stabilizer
Drug: Mood stabilizer
New initiation of lithium or any mood stabilizing anti-epileptic drug




Primary Outcome Measures :
  1. Psychiatric Hospitalization [ Time Frame: One year ]
    Number of participants hospitalized for a mental health reason


Secondary Outcome Measures :
  1. Emergency Department Visit for Mental Health Reason [ Time Frame: One year ]
    Number of Participants with an Emergency Department visit for mental health reason

  2. Death [ Time Frame: One year ]
    Participants who died



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults diagnosed with schizophrenia who are taking only a single antipsychotic medication who initiate treatment with an additional psychotropic medication.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Medicare recipients
  • Patients receiving clozapine
  Study Documents (Full-Text)

Documents provided by Scott Stroup, Columbia University:
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Responsible Party: Scott Stroup, Professor, Columbia University
ClinicalTrials.gov Identifier: NCT02775864    
Other Study ID Numbers: 7226
First Posted: May 18, 2016    Key Record Dates
Results First Posted: June 7, 2019
Last Update Posted: June 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Antidepressive Agents
Psychotropic Drugs
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs