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

NCT06331286 | Unknown DMC

• 1 other identifier: IIT20230091C-R1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Obesity; Cognition

Outcome Measures

Primary Outcomes (7)

• weight

  To analysis whether weight shows any significant trend with time changes.

  Baseline, the end of Week 12 and the end of Week 24

• Concentration of blood glucose in blood

  To analysis whether concentration of blood glucose in blood show any significant trend with time changes.

  Baseline, the end of Week 12 and the end of Week 24

• Concentration of total cholesterol in blood

  To analysis whether concentration of total cholesterol in blood show any significant trend with time changes.

  Baseline, the end of Week 12 and the end of Week 24

• Concentration of high density lipoprotein in blood

  To analysis whether concentration of high density lipoprotein in blood show any significant trend with time changes.

  Baseline, the end of Week 12 and the end of Week 24

• Concentration of low density lipoprotein in blood

  To analysis whether concentration of low density lipoprotein in blood show any significant trend with time changes.

  Baseline, the end of Week 12 and the end of Week 24

• Concentration of triglyceride in blood

  To analysis whether concentration of triglyceride in blood show any significant trend with time changes.

  Baseline, the end of Week 12 and the end of Week 24

• CBCT test results

  CBCT is a tool to measure cognitive function. It includes 4 dimensions: wire test, symbol encoding, continuous operation, and digital breadth.The wired test reflects the dimension of the speed of patient information processing. Symbolic coding reflects the patient's information processing speed, attention, working memory, reasoning, and problem-solving dimensions. Continuous manipulation reflects the patient's attention Dimension. The numerical breadth reflects the patient's working memory dimension.The basic information of the completion of each assessment and the completion of each assessment are calculated by the Chinese population norm model T-score, Deficit value, and extent and dimension of damage. Reflected in each assessment and the percentiles of neurocognitive function in the Chinese population.

  Baseline, the end of Week 12 and the end of Week 24

Secondary Outcomes (2)

• 17-item Hamilton Depression Rating Scale (HAM-D17) Score

  Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24

• Treatment Emergent Symptom Scale (TESS) Score

  Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24

Study Arms (2)

dulaglutide injection treatment group

EXPERIMENTAL

0.75mg Subcutaneous injection once a week for 24 weeks

Drug: dulaglutide injection

diet and exercise guidance treatment

OTHER

diet and exercise guidance treatment for 24 weeks

Drug: dulaglutide injection

Interventions

dulaglutide injection DRUG

0.75mg Subcutaneous injection once a week for 24 weeks

Also known as: diet and exercise guidance treatment

diet and exercise guidance treatment; dulaglutide injection treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder; Obesity

Interventions

dulaglutide; Diet

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Shaohua Hu

  Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Shaohua Hu, doctor

CONTACT

13957162903; dorhushaohua@zju.edu.cn

Shaojia Lu, doctor

CONTACT

13777878093; ronaldo0319@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 26, 2024
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)