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A Placebo-Controlled, Cross-Over Trial of Aripiprazole

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00351936
First Posted: July 13, 2006
Last Update Posted: February 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
David C. Henderson, MD, Harvard University
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by David C. Henderson, MD, Harvard University:

Primary Outcome Measures:
  • Change From Baseline in Weight (Lbs) [ Time Frame: baseline, week 4 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 12, 2006
First Posted: July 13, 2006
Results First Submitted: December 20, 2012
Results First Posted: January 28, 2013
Last Update Posted: February 4, 2013
Last Verified: January 2013

Keywords provided by David C. Henderson, MD, Harvard University:
Schizophrenia
Diabetes
Obesity
Olanzapine
Insulin Resistance

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents