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A Placebo-Controlled, Cross-Over Trial of Aripiprazole

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
David C. Henderson, MD, Harvard University
ClinicalTrials.gov Identifier:
NCT00351936
First received: July 12, 2006
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated patients with schizophrenia or schizoaffective disorder. The advantage of the crossover design is that each subject will act as their own control and fewer subjects will be required than a between-group design.


Condition Intervention Phase
Schizophrenia
 Drug: Aripiprazole
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Cross-Over Trial of Aripiprazole Added to Obese Olanzapine-Treated Patients With Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Suffolk Mental Health Association:

Primary Outcome Measures:
  • Change From Baseline in Weight (Lbs) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

  • Change From Baseline in Body Mass Index (BMI) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    Evaluating change in Body Mass Index (BMI) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

  • Change From Baseline in Waist-hip Ratio (WHR) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    Evaluating change in waist-hip ratio (WHR) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

  • Change From Baseline in Fasting Total Cholesterol [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    Evaluating change in fasting total cholesterol between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

  • Change From Baseline in Low-density Lipoprotein (LDL) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    Evaluating change in low-density lipoprotein (LDL) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

  • Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    Evaluating change in high-density lipoprotein cholesterol (HDL-C) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

  • Change From Baseline in Triglycerides [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    Evaluating change in triglyceride levels between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.


Enrollment: 16
Study Start Date: December 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aripiprazole
aripiprazole 15mg/day
 Drug: Aripiprazole
Placebo Comparator: placebo
matched placebo for aripiprazole 15mg/day
 Drug: placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female
  • Age 18-65
  • Diagnosis of schizophrenia, any subtype, or schizoaffective disorder, any sub-type
  • Body mass index > 30 Kg/m2 or >27 Kg/m2 with other risk factors (HTN, Lipid abnormalities)
  • Well established compliance with outpatient medications.
  • Maintained on a stable dose of olanzapine for at least one month.

Exclusion Criteria:

  • Serious medical or neurological illness (unstable cardiac disease, malignancy, liver or renal impairment, etc.)
  • Current substance abuse
  • Psychiatrically unstable, which is defined as a score on the CGI's severity of illness question of 5 or greater or a baseline Total PANSS score > 75
  • Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
  • Serious suicidal or homicidal risk within the past three months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351936

Locations
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
North Suffolk Mental Health Association
Eli Lilly and Company
Investigators
Principal Investigator: David C Henderson, MD North Suffolk Mental Health Association
  More Information

Publications:

Responsible Party: David C. Henderson, MD, Associate Professor of Psychiatry, Harvard University
ClinicalTrials.gov Identifier: NCT00351936     History of Changes
Other Study ID Numbers: 19-2005
Study First Received: July 12, 2006
Results First Received: December 20, 2012
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Suffolk Mental Health Association:
Schizophrenia
Diabetes
Obesity
Olanzapine
Insulin Resistance

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013