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A Self-Controlled Study on Changes in Butyrate-Producing Gut Microbiota Abundance and Inflammatory Factor Levels in Patients with Bipolar Depression Treated with Quetiapine

A Self-Controlled Study on Changes in Butyrate-Producing Gut Microbiota Abundance and Inflammatory Factor Levels in Patients with Bipolar Depression Treated with Quetiapine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127632
Enrollment
Unknown
Registered
2026-07-03
Start date
2026-07-03
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bipolar disorder

Interventions

Treatment Group:Oral quetiapine, starting at 50mg/day, titrated up based on tolerance and efficacy within 2 weeks, with a treatment dose range of 200-400mg/day, for a

Sponsors

Hebei Provincial Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65 years, regardless of gender; 2. Patients meet the diagnostic criteria for a depressive episode of Bipolar I Disorder or Bipolar II Disorder according to DSM-5; 3. HAMD-17 score >= 18 and HCL-32 score < 14; 4. No history of clear respiratory, urinary, digestive tract, or other infections within 1 month prior to enrollment; 5. No medication treatment (such as antidepressants, antipsychotics, mood stabilizers, etc.) within 1 week prior to enrollment; 6. BMI < 30 kg/m^2; 7. Understand the content of this study, able to cooperate in completing all study procedures, and provide written informed consent from the participant or their guardian.

Exclusion criteria

Exclusion criteria: 1. Exclude those diagnosed with other comorbid psychiatric disorders. 2. Exclude those who have used antibiotics within the past 4 weeks. 3. Exclude those who have used probiotics, prebiotics, or synbiotics within the past 4 weeks. 4. Exclude those who have undergone major gastrointestinal surgery (excluding cholecystectomy and appendectomy) in the past 5 years, or any history of intestinal resection, or active gastrointestinal disorders, including inflammatory bowel disease, ulcerative colitis, Crohn's disease, or active infectious gastroenteritis, colitis, or gastritis. 5. Exclude those currently experiencing severe suicidal ideation or behavior. 6. Exclude pregnant or breastfeeding women, or those planning pregnancy. 7. Exclude patients with contraindications to the study medication. 8. Exclude vegetarians, strict carnivores, or individuals with severely unbalanced dietary habits.

Design outcomes

Primary

MeasureTime frame
Inflammatory Cytokine Levels;Hamilton Depression Rating Scale-17 Total Score;Relative Abundance of Butyrate-Producers;

Countries

China

Contacts

Public ContactLiu Xinglong

Hebei Provincial Mental Health Center

1823837355@qq.com+86 312 7557036

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026