Using dulaglutide to improve cognitive function in obese patients with bipolar disorder
The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity
This study is testing if dulaglutide can help improve thinking skills in obese adults with bipolar disorder while they also follow a diet and exercise plan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06331286 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of dulaglutide, a GLP-1 receptor agonist, as an additional treatment for patients with bipolar disorder who also have obesity. It involves 60 participants aged 18 to 65, who are randomly assigned to receive either dulaglutide injections or diet and exercise guidance over a 24-week period. The study aims to assess changes in cognitive function and monitor any adverse events throughout the treatment duration. Participants are evaluated at multiple time points to determine the efficacy of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of bipolar disorder and a body mass index (BMI) of 28 or higher.
Not a fit: Patients who have undergone ECT therapy recently, are pregnant or lactating, or have certain hearing impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance cognitive function in patients with bipolar disorder and obesity, potentially improving their overall quality of life.
How similar studies have performed: While the specific combination of dulaglutide for cognitive function in bipolar disorder is novel, similar studies with GLP-1 receptor agonists have shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:a. Patients (or their legal representatives/guardians) sign off-label medication and informed consent; b. 16≤ age≤ 65 years old, gender is not limited; c. Patients in the stable phase who meet the diagnostic criteria for DSM-V bipolar disorder using a short-form international neuropsychiatric interview and have kept their current medication unchanged for at least 2 months after enrollment; Body mass index (BMI) ≥28 kg/m2 ;e. Young's Mania Scale (YMRS) ≤6 points; f. HAMD-24\<8 points; Han Chinese; Completed compulsory education at or above junior high school; Exclusion Criteria:Subjects related: a. Patients who have undergone ECT therapy within 3 months; b. Have a hearing problem (inability to hear or understand the examiner's speech under normal conversation); c. Pregnant, lactating women or planning to become pregnant; d. Those who are allergic to the study drug. Lesion-related: a. History of loss of consciousness due to cerebral organic disease or head trauma; b. Patients with any significant or unstable history of cardiovascular, respiratory, neurological (including epilepsy or significant cerebrovascular disease), renal, hepatic, or immune diseases, including inflammatory bowel disease, thyroid cancer, acute pancreatitis, etc., who are taking sulfonylurea drugs, anti-inflammatory or immunological agents, etc., especially those with a personal history or family history of medullary thyroid cancer (MTC) or 2 Patients with multiple endocrine neoplasia syndrome (MEN 2); c. Known, clinically significant laboratory markers or ECG abnormalities; Has any disease, liver disease, or renal disease that may alter the absorption, metabolism, or excretion of the study drug; d. Those with severe suicidal ideation and behavior or MARDS ≥ 30 points. Exclusion criteria related to concomitant medications: a. chronic use of anticholinergics; b. history of psychoactive substance abuse and dependence;
Where this trial is running
Hangzhou, Zhejiang
- Department of Psychiatry, First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Shaohua Hu, doctor
- Email: dorhushaohua@zju.edu.cn
- Phone: 13957162903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.