The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity

What Was Tested

The trial (not phased) is built around Dulaglutide.

The primary objective of this study is to investigate the effect of dulaglutide adjuvant treatment in patients with bipolar disorder with obesity, in addition to exploring the effect of GLP-1RA on cognition of bipolar disorder.

It had two arms (groups): dulaglutide injection treatment group (experimental) and diet and exercise guidance treatment (other).

Diet and exercise guidance treatment for 24 weeks.

The registry classes the interventions as drug.

More on the Plan

Characteristics, composition, mechanism of action and research scope of research drugs 3.1 Dulaglutide Injection has been approved for marketing by the National Medical Products Administration (NMPA S20190022).

Who Took Part

60 planned participants were the target.

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.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Dulaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Dulaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Dulaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-09-01 with completion listed for 2024-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): weight (time frame: Baseline, the end of Week 12 and the end of Week 24). Concentration of blood glucose in blood (time frame: Baseline, the end of Week 12 and the end of Week 24). Concentration of total cholesterol in blood (time frame: Baseline, the end of Week 12 and the end of Week 24).

It also tracked 2 secondary outcomes, for example 17-item Hamilton Depression Rating Scale (HAM-D17) Score and Treatment Emergent Symptom Scale (TESS) Score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Dulaglutide in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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