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Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)

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ClinicalTrials.gov Identifier: NCT03158805
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Susan McElroy, Lindner Center of HOPE

Brief Summary:
Taken together these data support the hypothesis that liraglutide 3.0 mg sc injection will reduce body weight and improve metabolic variables in obese or overweight patients with BP without worsening psychiatric symptoms. The investigators predict that liraglutide 3.0 mg sc injection will display greater efficacy as compared to placebo in decreasing body weight in patients with BP who are obese or overweight. To prove this hypothesis, investigators will conduct a single-center, randomized, placebo-controlled, double-blind, parallel-group, 2-arm clinical trial of liraglutide 3.0 mg sc injection in 60 obese or overweight outpatients with stable BP. The investigators have chosen BP rather than another SMI because it is the most common SMI (more common than schizophrenia or schizoaffective disorder) and has a particularly strong association with obesity.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Obesity Drug: LIRAGLUTIDE Other: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will conduct a single-center, randomized, placebo-controlled, double-blind, parallel-group, 2-arm clinical trial of liraglutide 3.0 mg sc injection in 60 obese or overweight outpatients with stable BP.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Study of Liraglutide 3mg Daily (Saxenda®) in Obese or Overweight Patients With Stable Bipolar Disorder
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Active drug
LIRAGLUTIDE 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)
Drug: LIRAGLUTIDE
3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)
Other Name: Saxenda

Placebo Comparator: Placebo
Placebo (no active drug)
Other: Placebo
Placebo injection




Primary Outcome Measures :
  1. Percent change in body weight [ Time Frame: 2 years ]
    The primary objective of this study is to evaluate the efficacy of liraglutide 3.0 mg sc injection(in combination with a reduced calorie diet and increased physical activity) compared with placebo for reducing body weight in obese or overweight adults with stable BP, as measured by percent change in body weight.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women, ages of 18-65 years, inclusive.
  2. Participants will have a DSM-5 bipolar disorder that is clinically stable.
  3. Participants will have received a stable major psychotropic drug regimen (except for minor dosage adjustments) for at least 3 months prior study entry. Major psychotropic drugs are antipsychotics, mood stabilizers, and antidepressants. Subjects may have had changes in adjunctive benzodiazepines and hypnotic agents.
  4. Participants will be obese (defined as a BMI ≥ 30 mg/kg2) or overweight (defined as BMI ≥ 27 kg/m2) with at least one weight-related comorbidity, such as hypertension, type 2 diabetes, or dyslipidemia.

5 Participants in treatment for a weight-related comorbidity (hypertension, type 2 diabetes, and/or dyslipidemia) must be on a stable and allowed treatment regimen for that condition for at least 3 months prior to study enrollment.

6 Participants will be able to provide informed consent before any trial-related activities.

Exclusion Criteria:

  1. Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. The following are considered to be adequate methods of birth control: 1.Intrauterine device (IUD); 2. Barrier protection; 3.Contraceptive implantation system (Norplant); 4.Oral contraceptive pills; 5. A surgically sterile partner; and 6. Abstinence. Women who are > 2 years post-menopausal or surgically-sterile are not considered of childbearing potential. All female participants will have a negative pregnancy test prior to randomization.
  2. Participants who have made a suicide attempt in the last 10 years, who are displaying clinically significant psychotic features, suicidality, or homicidality on mental status examination, or who have suicidal ideation or behavior as assessed with the C-SSRS.
  3. Participants who are receiving behavioral weight loss treatment (BWLT) (e.g., Weight Watchers) that was begun within the 3 months before study entry. Participants who are receiving BWLT that was started 3 months prior to the beginning of the study will be allowed to continue to receive their BWLT during the trial only if they have had no weight loss in the past 3 months and they agree to not make any changes in the frequency or nature of their BWLT during the course of the drug trial.
  4. A DSM-5 diagnosis of a substance-related or addictive disorder (except a tobacco-related disorder) within the 3 months prior to enrollment.
  5. A DSM-5 diagnosis of dementia, a psychotic disorder, or a depressive disorder.
  6. History of any psychiatric disorder which might interfere with a diagnostic assessment, treatment, or compliance.
  7. Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, neurological, metabolic, endocrine, or other systemic disease. Clinically stable hypertension, type 2 diabetes, or dyslipidemia are not exclusionary.
  8. Have a history of a structural cardiac abnormality, valvular cardiac disease, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, congestive heart failure, stroke, or other serious cardiovascular problem.
  9. Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation.
  10. Have clinically relevant abnormal laboratory results.
  11. Participants requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes anti-obesity drugs, psychostimulants, modafinil or armodafinil, topiramate or zonisamide, and antipsychotics. Participants receiving metformin at a stable dose for ≥ 3 months can be included.
  12. Participants receiving GLP-1 based therapies, sodium-glucose co-transporter 2 inhibitors (SGLT2s), thiazolidinediones, sulfonylureas, or insulin.
  13. Participants with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
  14. Participants who have received any investigational medication within three months prior to randomization.
  15. Participants previously screen-failed or randomised to participate in this trial.
  16. Participants who have a known or suspected allergy to liraglutide 3.0 mg sc injection, its constituents, or related products.
  17. Participants with a urine drug screen positive for a drug that, in the opinion of the investigator, is being abused.
  18. Participants with a past medical history of pancreatitis.
  19. Participants who had received any investigational drug within 3 months prior to this trial.
  20. Participants who require bariatric surgery or are anticipated to require it during the course of the trial. If such surgery becomes warranted during the study, such patients will be excluded from the primary endpoint analysis.

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): NCT03158805


Contacts
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Contact: Anna Guerdjikova, PhD 513-536-0700 anna.guerdjikova@lindnercenter.org
Contact: Susan McElroy, MD 513-536-0700 susan.mcelroy@lindnercenter.org

Locations
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United States, Ohio
Lindner Center of HOPE Recruiting
Mason, Ohio, United States, 45040
Contact: Anna Guerdjikova, PhD    513-536-0700    anna.guerdjikova@lindnercenter.org   
Contact: Susan McElroy, MD    513-536-0700    susan.mcelroy@lindnercenter.org   
Principal Investigator: Susan McElroy, MD         
Sponsors and Collaborators
Lindner Center of HOPE

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Responsible Party: Susan McElroy, Chief Research Officer, Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT03158805     History of Changes
Other Study ID Numbers: 2017-1579
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Liraglutide
Disease
Overweight
Bipolar Disorder
Pathologic Processes
Body Weight
Signs and Symptoms
Bipolar and Related Disorders
Mental Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists