Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia

NCT02775864 | Completed Results

• 1 other identifier: 7226
• Study Type: observational
• Target: 81,921
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Psychiatric Hospitalization

  Number of participants hospitalized for a mental health reason

  One year

Secondary Outcomes (2)

• Emergency Department Visit for Mental Health Reason

  One year

• Death

  One year

Study Arms (4)

Antipsychotic

Individuals initiating treatment with an antipsychotic medication

Drug: Antipsychotic

Antidepressant

Individuals initiating treatment with an antidepressant medication

Drug: Antidepressant

Benzodiazepine

Individuals initiating treatment with a benzodiazepine

Drug: Benzodiazepine

Mood stabilizer

Individuals initiating treatment with a mood stabilizer

Drug: Mood stabilizer

Interventions

Antipsychotic DRUG

New initiation of any antipsychotic medication

Antipsychotic

Antidepressant DRUG

New initiation of any antidepressant medications

Antidepressant

Benzodiazepine DRUG

New initiation of any benzodiazepine

Benzodiazepine

Mood stabilizer DRUG

New initiation of lithium or any mood stabilizing anti-epileptic drug

Mood stabilizer

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Medicare recipients
• Patients receiving clozapine

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Rutgers University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Antipsychotic Agents; Antidepressive Agents; Benzodiazepines

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Scott Stroup
• Organization: Columbia University

Scott.Stroup@nyspi.columbia.edu

646-774-8435

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 18, 2016
• Study Start: July 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 1, 2024
• Results First Posted: June 7, 2019

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share