Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults - Full Text View

Sponsor:	University of Cincinnati
Collaborator:	Eli Lilly and Company
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00845507

Purpose

The purpose of this research study is to test the safety and efficacy (how well it works) of exenatide as a treatment for weight gain associated with olanzapine in obese adults with Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder

Exenatide has been approved by the FDA for the treatment of Type 2 diabetes.

It has not been approved for the treatment of weight gain associated with olanzapine in obese adults with bipolar disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder

Condition	Intervention	Phase
Weight Gain	Drug: Exenatide or placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind Placebo-Controlled Study of Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults With Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression Mental Disorders Obesity Psychotic Disorders Schizophrenia

Drug Information available for: Olanzapine Exenatide

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

The primary outcome measure will be change in weight from baseline to endpoint. [ Time Frame: Baseline to endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in body mass index, abdominal circumference, metabolic parameters, clinical global improvement of psychiatric symptoms, change in manic, depressive and psychotic symptoms. Rates of adverse events will also be assessed. [ Time Frame: baseline to endpoint ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Exenatide vs. Placebo	Drug: Exenatide or placebo the dosage of study medication will be 5 mcg sc of exenatide or placebo twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg sc twice daily. Other Name: Exenatide
Experimental: 2 Exenatide vs. Placebo	Drug: Exenatide or placebo the dosage of study medication will be 5 mcg sc of exenatide or placebo twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg sc twice daily. Other Name: Exenatide

Detailed Description:

Double-blind studies suggest that olanzapine is highly effective for the treatment of individuals with bipolar disorder. However, weight gain and impaired glucose tolerance remain significant concerns associated with olanzapine. Exenatide is an anti-diabetic medication that is associated with weight loss and improved glucose regulation. Therefore, the overall goal of the proposed study is to conduct a 16-week double-blind placebo-controlled study of exenatide for the treatment of weight gain associated with olanzapine in 60 obese adults with bipolar disorder treated with olanzapine. We propose to conduct the study over the course of 24 months, with an expected enrollment of approximately 3 patients per month. The primary outcome measure will be change from baseline to endpoint in weight. The secondary outcome measures will include changes from baseline to endpoint, in body mass index (BMI), abdominal circumference, metabolic parameters, clinical global improvement of psychiatric symptoms, and change in manic, depressive and psychotic symptoms. Rates of adverse events also will be assessed.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must be between the ages of 18 and 55 years old.
Subjects must have bipolar I disorder, schizophrenia, schizoaffective disorder or MDD as defined by DSM-IV-TR criteria and diagnosed using the Structured Clinical Interview for DSM-IV (SCID).
Subjects must have a Young Mania Rating Scale (YMRS) score < 16 and a Montgomery-Asberg Depression Rating Scale (MADRS) score < 24 at screening and baseline visits.
Subjects must have the Scale for the Assessment of Positive Symptoms (SAPS) scores <2 on all subscales.
Subjects must have gained > 7% of their body weight following treatment with olanzapine as either documented in their medical records or by patient report.
Subjects must be obese, as defined by a current Body Mass Index (BMI) > 30 kg/m2.
Subjects must sign the Informed Consent Document after the nature of the trial has been fully explained.
If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable method(s) of contraception (e.g., hormonal methods, intrauterine device, abstinence) for at least one month prior to study entry and throughout the study.
Subjects must be on a stable dose of olanzapine for at least 14 days and must have been on 5-30mg/day for at least 1 month.

Major Exclusion Criteria

Subjects with clinically significant suicidal or homicidal ideation.
Subjects who have a DSM-IV lifetime diagnosis of a substance dependence disorder within the past 6 months or within the past month have been diagnosed with a substance abuse disorder, (except for nicotine abuse or dependence), as determined by psychiatric history or SCID interview.
Subjects with a clinically significant or unstable medical disease, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions, that could interfere with diagnosis, assessment, or treatment of bipolar disorder or obesity, as well as subjects with a history of pancreatitis.
Patients with clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices or clinically abnormal ECG.
Female patients who are either pregnant or lactating.
Any female patient whose sexual activity is unknown or in questions.
Any history of current or past diabetes that has been treated with pharmacological intervention. Subjects who have a diagnosis of diabetes, are currently receiving exenatide, insulin, or an oral anti-hyperglycemic medication, or who have a nonfasting blood glucose ≥ 200 mg/dl or a fasting blood glucose ≥126 mg/dl on 2 separate tests. Subjects with pre-diabetes will not be excluded.
Neurological disorders including epilepsy, stroke, or severe head trauma. Mental retardation (IQ <70).

10. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.

11. Treatment with concurrent mood stabilizers (except lithium), anticonvulsants, or antipsychotics.

12. Other psychotic disorders (including delusional disorder, brief psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.

13. Dysthymic disorder or depressive disorder not otherwise specified, bipolar disorder not otherwise specified.

14. Subjects previously enrolled in this study or have previously been treated with exenatide.

15. Subjects who have received an experimental drug within 30 days. 16. Subjects who are displaying current clinically significant depressive or manic symptoms, defined as a MADRS score >24 or a YMRS score > 16 or who currently meet DSM-IV-TR criteria for a manic, mixed, hypomanic, or depressive episode.

17. Subjects who are displaying current clinically significant psychotic symptoms, defined as any SAPS subscale score > 2 18. Subjects with a history of pancreatitis in themselves or any risk factors for developing pancreatitis (risk factors include but are not limited to: alcohol use, history of gallbladder disease or gallstones, diabetes or a family history of pancreatitis) 19. Subjects with elevated amylase or lipase levels as measured at the screening visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845507

Contacts

Contact: Emily Rummelhoff

513-558-4295

emily.rummelhoff@uc.edu

Locations

United States, Ohio
University of Cincinnati	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Emily Rummelhoff 513-558-4295 emily.rummelhoff@uc.edu
Principal Investigator: Melissa DelBello, MD

Sponsors and Collaborators

University of Cincinnati

Eli Lilly and Company

Investigators

Principal Investigator:

Melissa DelBello, MD

University of Cincinnati

More Information

No publications provided

Responsible Party:	Melissa DelBello, MD/Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00845507 History of Changes
Other Study ID Numbers:	Exenatide
Study First Received:	February 16, 2009
Last Updated:	February 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

weight gain

Additional relevant MeSH terms:

Body Weight
Psychotic Disorders
Depressive Disorder, Major
Weight Gain
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Depressive Disorder
Mood Disorders
Body Weight Changes
Exenatide
Olanzapine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
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 February 09, 2012