Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Cincinnati
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Melissa Delbello, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00845507
First received: February 16, 2009
Last updated: March 13, 2014
Last verified: March 2014
  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
Phase 4

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:


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: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide Group
Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.
Drug: Exenatide
The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
Other Name: Exenatide (Byeta)
Placebo Comparator: Placebo Group
Placebo: Sterile solution in equivalent doses as Exenatide
Drug: Exenatide
The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
Other Name: Exenatide (Byeta)

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:

  1. Subjects must be between the ages of 18 and 55 years old.
  2. 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).
  3. 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.
  4. Subjects must have the Scale for the Assessment of Positive Symptoms (SAPS) scores <2 on all subscales.
  5. Subjects must have gained > 7% of their body weight following treatment with olanzapine as either documented in their medical records or by patient report.
  6. Subjects must be obese, as defined by a current Body Mass Index (BMI) > 30 kg/m2.
  7. Subjects must sign the Informed Consent Document after the nature of the trial has been fully explained.
  8. 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.
  9. 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

  1. Subjects with clinically significant suicidal or homicidal ideation.
  2. 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.
  3. 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.
  4. 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.
  5. Female patients who are either pregnant or lactating.
  6. Any female patient whose sexual activity is unknown or in questions.
  7. 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.
  8. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00845507     History of Changes
Other Study ID Numbers: Exenatide
Study First Received: February 16, 2009
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
weight gain

Additional relevant MeSH terms:
Body Weight
Weight Gain
Signs and Symptoms
Body Weight Changes
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014