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

What Was Tested

The trial (phase 2) is built around Liraglutide.

It had two arms (groups): Active drug (active comparator) and Placebo (placebo comparator).

Placebo (no active drug).

The registry classes the interventions as drug and other.

More on the Plan

Importantly, obesity is thought to contribute to the well-documented elevated mortality from cardiovascular disease (CVD) among those with BP.

It is thus imperative that obesity be a focus of treatment in those with BP.

In December 2014, the U.S.

Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women, ages of 18-65 years, inclusive. Participants will have a DSM-5 bipolar disorder that is clinically stable.

The full record lists 4 inclusion and 20 exclusion criteria; among the exclusions: A DSM-5 diagnosis of a substance-related or addictive disorder (except a tobacco-related disorder) within the 3 months prior to enrollment; A DSM-5 diagnosis of dementia, a psychotic disorder, or a depressive disorder; history of any psychiatric disorder which might interfere with a diagnostic assessment, treatment, or compliance.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-04-26 with completion listed for 2022-10-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change in Body Weight (time frame: 40 week).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 60 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.