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

March 20, 2024 updated by: First Affiliated Hospital of Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Department of Psychiatry, First Affiliated Hospital of Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dulaglutide injection treatment group
0.75mg Subcutaneous injection once a week for 24 weeks
Drug: dulaglutide injection
0.75mg Subcutaneous injection once a week for 24 weeks
Other Names:
  • diet and exercise guidance treatment
Other: diet and exercise guidance treatment
diet and exercise guidance treatment for 24 weeks
Drug: dulaglutide injection
0.75mg Subcutaneous injection once a week for 24 weeks
Other Names:
  • diet and exercise guidance treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: Baseline, the end of Week 12 and the end of Week 24
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
Time Frame: Baseline, the end of Week 12 and the end of Week 24
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
Time Frame: Baseline, the end of Week 12 and the end of Week 24
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
Time Frame: Baseline, the end of Week 12 and the end of Week 24
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
Time Frame: Baseline, the end of Week 12 and the end of Week 24
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
Time Frame: Baseline, the end of Week 12 and the end of Week 24
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
Time Frame: Baseline, the end of Week 12 and the end of Week 24

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
17-item Hamilton Depression Rating Scale (HAM-D17) Score
Time Frame: Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24
HAM-D17 has been the gold standard for the assessment of depression. The score needs to be based on clinical interviews, and the time frame of the assessment is usually the situation in the previous week. Most items use a 5-point scale of 0 to 4. The standard of each level is: 0 indicates none, 1 indicates mild, 2 indicates moderate, 3 indicates severe, and 4 indicates extremely severe. A few items adopt the 3-level scoring method with 0~2 points, and the grading standard is: 0 indicates none, 1 indicates mild to moderate and 2 indicates severe.
Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24
Treatment Emergent Symptom Scale (TESS) Score
Time Frame: Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24
Treatment Emergent Symptom Scale was developed by The National Institute of Mental Health (NIMH) in the USA in 1973. It is a safety assessment tool after treatment of psychiatric diseases. Evaluation is based on patient reports, physical examination results, and laboratory reports, and some items should also be consulted with the patient's family. Severity item is scored from 0 (not present) to 4 (severe). Higher scores represent a more severe condition.
Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Investigators

  • Study Director: Shaohua Hu, Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20230091C-R1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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