Schizophrenia
Conditions
Brief 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.
Detailed description
Over the past several years, new, "atypical" antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients. Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or aripiprazole. Participants currently taking a single conventional injectable will begin taking long-acting injectable risperidone (Risperdal Consta). Participants currently taking two antipsychotic medications will begin taking only one of the medications they are currently using. Participants will stay on their assigned treatment for 6 months, after which time the participant's prescribing psychiatrist will advise the participant on which medication should be used. Study participants are interviewed at study start and at follow-up visits for 1 year.
Interventions
DRUGRisperidone
As prescribed by routine prescriber (not dictated by study protocol)
DRUGOlanzapine
As prescribed by routine prescriber (not dictated by study protocol)
DRUGZiprasidone
As prescribed by routine prescriber (not dictated by study protocol)
DRUGQuetiapine
As prescribed by routine prescriber (not dictated by study protocol)
DRUGAripiprazole
As prescribed by routine prescriber (not dictated by study protocol)
Sponsors
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number Who Discontinued Medication Within First 6 Study Months | Measured at Six Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Hospitalized | during first 6 months | Number of participants hospitalized for psychiatric reasons |
Contacts
STUDY_CHAIRSusan M. Essock, PhD
Columbia University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stay Participants will continue taking medication prescribed at study entry | 102 |
| Switch Participants will change medications from medication prescribed at study entry | 117 |
| Total | 219 |
Baseline characteristics
| Characteristic | Switch | Stay | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 112 Participants | 96 Participants | 208 Participants |
| Age, Continuous | 47.7 years STANDARD_DEVIATION 11.3 | 46.9 years STANDARD_DEVIATION 10.4 | 46.9 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 117 participants | 102 participants | 219 participants |
| Sex: Female, Male Female | 31 Participants | 42 Participants | 73 Participants |
| Sex: Female, Male Male | 86 Participants | 60 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 0 / 102 | 0 / 117 |
| serious Total, serious adverse events | 0 / 102 | 2 / 117 |
Outcome results
Primary
Number Who Discontinued Medication Within First 6 Study Months
Time frame: Measured at Six Months
Population: intent to treat samples for 2 substudies: injectable to injectable and polypharmacy to monotherapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stay | Number Who Discontinued Medication Within First 6 Study Months | 11 participants |
| Switch | Number Who Discontinued Medication Within First 6 Study Months | 23 participants |
Secondary
Psychiatric Symptoms, Hospitalization, and Medication Side Effects
Time frame: Measured at Year 1