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Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia

Information source: National Institute of Mental Health (NIMH)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Olanzapine (Drug); Perphenazine (Drug); Aripiprazole (Drug); Metformin (Drug); Simvastatin (Drug); Benztropine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Marvin Swartz, MD, Principal Investigator, Affiliation: Duke University
T. Scott Stroup, MD, MPH, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill
Joseph P. McEvoy, MD, Principal Investigator, Affiliation: Duke University

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.

Clinical Details

Official title: Comparison of Optimal Antipsychotic Treatments for Schizophrenia Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study

Secondary outcome: Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment

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 often taken for long periods of time, and can have severe side effects. Other, secondary medications can provide relief from some of the most common severe side effects. This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of additional medications to limit treatment side effects, in adults with schizophrenia. Participation in this study will last 28 to 30 weeks and include 11 visits to a study clinic. Each visit will last 2 to 3 hours. The first 2 visits will include screening and baseline measurements. The screening visit will take place at study entry, and the baseline visit will take place 3 to 14 days later. Study visits will then occur 1, 2, and 4 weeks after the baseline visit, followed by monthly visits. At the baseline visit participants will be randomly assigned to receive olanzapine, perphenazine, or aripiprazole for 28 weeks. Dosage for all three antipsychotic medications will start at low levels and be increased to full strength over 2 weeks. If participants are taking another antipsychotic when they enter the study, this 2-week period will also be used to slowly reduce and then end treatment with the non-study antipsychotic. Side effects to all three antipsychotics will be monitored, and, depending on the side effect, one of three different medications will be added to the treatment regimen. If increased cholesterol levels are experienced with any antipsychotic, simvastatin will be added; if weight gain is experienced, metformin will be added; if involuntary movements, inner restlessness, or muscle stiffness are experienced, benztropine will be added. Because of already known side effects, participants assigned to olanzapine or perphenazine will automatically add metformin or benztropine, respectively, to their regimens. Starting on the third study visit, participants will also undergo a behavioral treatment aimed at reducing cardiovascular risk factors. This behavioral treatment will involve nine 20-minute sessions, with phone calls being made to participants between sessions. During each study visit, assessments will be made of schizophrenia symptoms, side effects, adherence to medication regimen, vital signs, waist circumference, and weight. Participants will also complete a questionnaire on use of health care services and undergo instructions on exercise and eating right. On visits 1, 5, 7, and 11, blood will be drawn for standard lab tests. Additional measures at the screening visit will include questions about medical and psychiatric history, a urine test for drugs, and a questionnaire about physical and social activities.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

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

Locations and Contacts

SHANTI Clinical Trials, Colton, California 92324, United States

Stanford University, Palo Alto, California 94305, United States

Yale University, New Haven, Connecticut 06519, United States

University of Miami School of Medicine, Miami, Florida 33316, United States

Medical College of Georgia, Augusta, Georgia 30912, United States

Clinical Insights, Glen Burnie, Maryland 21061, United States

University of Massachusetts, Worcester, Massachusetts 01605, United States

Wayne State University, Detroit, Michigan 48201, United States

University of Minnesota School of Medicine, Minneapolis, Minnesota 55454, United States

Research Foundation for Mental Hygiene, New York, New York 10032, United States

Duke University Medical Center-John Umstead Hospital, Butner, North Carolina 27509, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75235, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Additional Information

Starting date: December 2008
Last updated: January 3, 2013

Page last updated: August 23, 2015

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