Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Mental Health (NIMH)
• Treatments: Antipsychotic Agents; Aripiprazole; Benztropine; Metformin; Olanzapine; Perphenazine; Simvastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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