Phase 4
Completed N=219
Switching Medication to Treat Schizophrenia
Source: ClinicalTrials.gov NCT00044655 ↗Enrolled (actual)
219
Serious AEs
0.9%
Results posted
Dec 2013
Primary outcomePrimary: Number Who Discontinued Medication Within First 6 Study Months — 11; 23 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Who Discontinued Medication Within First 6 Study Months |
11; 23 | — |
| SECONDARY Number of Participants Hospitalized |
8; 9 | — |
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00044655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.