Clinical trial NCT06331286: The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity
Official title: The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Obesity
Cognition
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 3. 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). Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist with a half-life of up to 4-7 days and supports once-weekly subcutaneous administration at a dose of 0.75 mg.

The study included 60 patients (aged 18 to 65 years) with bipolar disorder with obesity who met the diagnostic criteria for bipolar disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), fifth edition.Eligible patients were randomly assigned (1:1) to 24-week treatment with dulaglutide injection (n=30) or diet and exercise guidance treatment (n=30), followed up at period of enrollment as baseline and at the end of 2th, 4th，8th ，12th ，16th and 24th weeks. Adverse events were recorded.

Eligibility 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;

Primary outcomes:
measure: weight
timeFrame: Baseline, the end of Week 12 and the end of Week 24
measure: Concentration of blood glucose in blood
timeFrame: Baseline, the end of Week 12 and the end of Week 24
measure: Concentration of total cholesterol in blood
timeFrame: Baseline, the end of Week 12 and the end of Week 24
measure: Concentration of high density lipoprotein in blood
timeFrame: Baseline, the end of Week 12 and the end of Week 24
measure: Concentration of low density lipoprotein in blood
timeFrame: Baseline, the end of Week 12 and the end of Week 24
measure: Concentration of triglyceride in blood
timeFrame: Baseline, the end of Week 12 and the end of Week 24
measure: CBCT test results
timeFrame: Baseline, the end of Week 12 and the end of Week 24
Secondary outcomes:
measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score
timeFrame: Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24
measure: Treatment Emergent Symptom Scale (TESS) Score
timeFrame: Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Psychiatry, First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine
name: Shaohua Hu
role: STUDY_DIRECTOR
References: