Bipolar DisorderNCT06331286
The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity
A study testing dulaglutide injection in people with Bipolar Disorder and Obesity, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Obesity, Cognition
- What is being tested?
- dulaglutide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Hu ShaoHua, 13957162903, dorhushaohua@zju.edu.cn
About this study
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.
Read the detailed description
- 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.
- Conditions
- Bipolar Disorder, Obesity, Cognition
- Being tested
- dulaglutide injection
- Medical subject headings
- Bipolar Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dulaglutide injectionDrug
Also called diet and exercise guidance treatment
0.75mg Subcutaneous injection once a week for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| dulaglutide injection treatment group | Experimental | 0.75mg Subcutaneous injection once a week for 24 weeks Receives: Drug: dulaglutide injection |
| diet and exercise guidance treatment | Other | diet and exercise guidance treatment for 24 weeks Receives: Drug: dulaglutide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
To analysis whether weight shows any significant trend with time changes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, the end of Week 12 and the end of Week 24
Secondary outcomes (2)
17-item Hamilton Depression Rating Scale (HAM-D17) Score
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.
Measured: Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24
Treatment Emergent Symptom Scale (TESS) Score
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.
Measured: Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaohua Hu, Study director, Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331286
- Sponsor's protocol ID
- IIT20230091C-R1
- Status last verified
- Aug 2023
- First submitted
- 20 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity
- ClinicalTrials.gov ID
- NCT06331286
- Acronym / sponsor ID
- IIT20230091C-R1
- Conditions
- Bipolar Disorder, Obesity, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dulaglutide injection treatment group | Experimental | Drug: dulaglutide injection0.75mg Subcutaneous injection once a week for 24 weeks |
| diet and exercise guidance treatment | Other | Drug: dulaglutide injectiondiet and exercise guidance treatment for 24 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dulaglutide injectionAlso: diet and exercise guidance treatment0.75mg Subcutaneous injection once a week for 24 weeks | Drug | diet and exercise guidance treatment, dulaglutide injection treatment group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
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
Treatment Emergent Symptom Scale (TESS) Score
Time frame: Time Frame: Baseline, the end of Week 2, 4， 8，12，16 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaohua Hu study director
Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dulaglutide injection in people with Bipolar Disorder and Obesity, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaohua Hu, doctor (13957162903, dorhushaohua@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: Baseline, the end of Week 12 and the end of Week 24). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.