Status:
COMPLETED
Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
Brief Summary
This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of other medications to limit treatment side effects, in adults with schizophrenia...
Detailed Description
Schizophrenia is a chronic brain disease affecting approximately 1% of Americans. Antipsychotic medications can treat some of the most severe symptoms of schizophrenia, but they are not a cure, are of...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
- Treated with antipsychotic medication for less than 5 years
- Adequate decisional capacity to make a choice about participating in this research study. Adequate decisional capacity will be determined through the aid of a 10-item decisional capacity quiz adapted from the University of California, San Diego, Brief Assessment of Capacity to Consent (UBACC) scale.
- Psychotic exacerbation within the month prior to study entry that required psychiatric hospitalization or an increased level of care
- Willing to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study. Acceptable methods include oral, injectable, or implanted contraceptives; intrauterine devices; or barrier methods, such as condoms, diaphragm, and spermicides.
Exclusion
- Body mass index at or above 35 kg/m2 or below 18 kg/m2
- Hemoglobin A1c level at or above 7%
- Hematocrit level at or above 31%
- Non-high density lipoprotein cholesterol at or above 190 mg/dL
- Triglycerides at or above 500 mg/dL
- Documented failure, defined as inefficacy or intolerability, with an adequate trial of olanzapine, perphenazine, or aripiprazole. Adequate trials last at least 4 weeks at a minimum dose of 15 mg/day of aripiprazole, 15 mg/day of olanzapine, or 16 mg/day of perphenazine.
- Current treatment with olanzapine, perphenazine, or aripiprazole for more than 1 month
- Known hypersensitivity to metformin, simvastatin, or benztropine
- Treatment with a medication prescribed for weight loss
- Diagnosis of diabetes mellitus or treatment with insulin or other diabetes medication
- Contraindications to metformin use, including any of the following:
- Diagnosis of congestive heart failure
- Renal impairment, defined as serum creatinine at or above 1.5 in males and 1.4 in females, or creatinine estimated glomerular filtration rate (GFR) outside of normal limits
- Hepatic disease, defined as aspartate transaminase (AST), alanine transaminase (ALT), or c-glutamyl transferase (CGT) more than 1.5 times upper limit of normal (ULN) or total bilirubin more than 1.2 times ULN
- Metabolic acidosis, defined as a serum CO2 level less than the lower limit of normal
- Recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material
- Alcohol abuse or dependence, as determined by SCID within the past month
- Concurrent treatment with certain drugs known to increase metformin blood levels
- Any unstable or serious medical condition, as judged by the investigator
- Pregnant or breastfeeding
- Diagnosis of mental retardation or delirium, as defined by the DSM-IV-TR
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00802100
Start Date
December 1 2008
End Date
October 1 2009
Last Update
February 8 2013
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
SHANTI Clinical Trials
Colton, California, United States, 92324
2
Stanford University
Palo Alto, California, United States, 94305
3
Yale University
New Haven, Connecticut, United States, 06519
4
University of Miami School of Medicine
Miami, Florida, United States, 33316