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

Part of paid clinical trials in Mason, Ohio.

Sponsor
Lindner Center of HOPE
Study ID
NCT03158805
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LIRAGLUTIDE — DRUG
    3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)
  • Placebo — OTHER
    Placebo injection

Study Details

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.

Key Dates

Start date
Apr 26, 2017
Status verified
Mar 2025
Primary completion
Oct 11, 2022
Completion
Jan 1, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active drug
    LIRAGLUTIDE 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)
  • Placebo Comparator: Placebo
    Placebo (no active drug)

Primary Outcome Measure

Percent Change in Body Weight [ Time Frame: 40 week ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lindner Center of HOPEMasonOhio45040-

Find similar trials in Mason, OH

By condition
Bipolar disorderObesity / overweight
By specialty
PsychiatryMental healthBehavioral healthEndocrinologyMetabolic healthWeight loss
By research site
Lindner Center of HOPE· Mason, OH

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