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Home > "S" Clinical Trials Conditions > Switching Medication to Treat Schizophrenia  Switching Medication to Treat Schizophrenia
Switching Medication to Treat Schizophrenia
For Condition: Schizophrenia
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to determine whether people with schizophrenia who are relatively stable on their medications but still have symptoms or medication side effects should switch to atypical antipsychotic medication.
Details: Over the past several years, new, "atypical" antipsychotic medications have become available to treat schizophrenia. These new medications may be more effective than the conventional ones and have fewer negative side effects. Participants are randomly assigned to receive olanzapine (Zyprexa), risperidone (Risperdal), or ziprasidone (Geodon) or to remain on their current conventional antipsychotic medication. Participants stay on their assigned treatment for 6 months, after which time medication decisions will be made by the patient and the prescribing psychiatrist. Study participants are interviewed at study start and at follow-up visits for 1 year.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 an oral conventional antipsychotic medication for at least 2 months - Received at least 1 Medicaid 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 2 or more antipsychotic medications for ongoing daily administration (PRN medications and mood stabilizers are allowable) - Treatment with olanzapine, risperidone, or ziprasidone - One or more nights spent in a psychiatric hospitalization within the past 3 months - Received services from a DMHAS crisis intervention program within the past 6 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 - The following cardiac conditions: QTc greater than 450 for men or greater than 470 for women, MI in the past 6 months, history of sustained cardiac arrhythmia, uncompensated congestive heart failure, complete left bundle branch block, first-degree heart block with PR greater then 0.22, or history of congenital QTc prolongation (for patients with borderline QTc prolongation, if there are no other factors that increase the risk for ventricular arrhythmia, the physician may choose whether to repeat the ECG or proceed. If there are other factors that increase the risk for ventricular arrhythmia, participants will have a repeat ECG. If the second ECG shows QTc borderline prolongation, the physician will obtain a cardiology consult before allowing study participation. If the second ECG shows QTc prolongation, the individual will be excluded from participation.) - Quinidine, dofetilide, pimozide, sotalol, thioridazine, moxiflaxacin, or sparfloxacin treatment
Total Enrollment: 300
Location and Contact Information:
Mount Sinai School of Medicine *Recruiting*
New York City, New York, 10029
United States
Recruiting
Additional Information:
Study ID Numbers: 59312-01A2;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044655
Other Schizophrenia Studies:
1. Clinical Study of Schizophrenia
2. TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices")
3. Study of Three Doses of Aripiprazole in Patients with Acute Schizophrenia
4. Safety and efficacy of study drug versus placebo for negative symptoms of schizophrenia
5. Clinical Trial of Tolcapone for Cognition in Schizophrenia
Related Studies:
Other Schizophrenia Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Switching Medication to Treat Schizophrenia
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