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Clinical trials of antidepressant mirtazapine for the treatment of functional dyspepsia patients with weight loss

Clinical trials of antidepressant mirtazapine for the treatment of functional dyspepsia patients with weight loss

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003161
Enrollment
Unknown
Registered
2013-03-06
Start date
2013-04-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Functional Dyspepsia with Weight loss

Interventions

A:Group A is treated with conventional therapy during 8 weeks
B:Group B is treated with conventional therapy in combination with Paroxetine during 8 weeks
C:Group C is treated with conventional therapy in combination with Mirtazapine during 8 weeks

Sponsors

Guangzhou Nansha Central Hospital, Guangzhou First People's Hospital Affiliated to Guangzhou Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients are from gastroenterology unit in Guangzhou Nansha Central Hospital who conform to the Rome III criteria for functional dyspepsia (patients must have one or more of following symptoms for at least 3 months with symptom onset at least 6 months previously: bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning with no evidence of structural disease, including the use of upper endoscopy, which is likely to explain the symptoms); 2. Patients with a weight loss of >=5% of the initial body weight since the onset of symptoms; 3. The diagnosis of depression is made by psychiatrists accorrding to CCMD-3 and the scores of HAMD over 18; 4. Aged from 18 years to 65 years; 5. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. organic diseases found during gastroscopy examination, such as peptic ulcers, atrophy or erosive gastroduodenal lesions, tumors,and esophagitis; 2. Laboratory, B ultrasonic, X-ray examination have found liver; gall; Pancreas, Spleen and bowel organic disease; 3. dyspepsia symptoms and weight loss that were explained by metabolic or infectious diseases such as diabetes, hyperthyroidism, tuberculosis; 4. anorexia nervosa and patients with body weight management; 5. Aged 65 years; 6. Pregnancy or breast feeding; 7. Disabled patients; 8. patients is Concurrently undergoing other drugs in clinical research or nearly half a month used the Similar drugs; 9. In a severe anxiety or depression state, or suicidal tendencies; 10. current use of non-steroidal anti-inflammatory drugs, steroids, or drugs affecting gastric acid secretion; 11. Contraindications or careful with Paroxetine and mirtazapine including: hypersensitivity; liver dysfunction or renal Failure.

Design outcomes

Primary

MeasureTime frame
The Nepean Dyspepsia Index (NDI)-symptom checklist;The Hamilton Rating Scale of Depression (HAMD);The number of barium strip expelled from stomach after 3 hours;Body weight;Appetite;Gastrointestinal hormone;Clinical Global Impression (CGI);side effect;

Secondary

MeasureTime frame
The Hamilton Rating Scale of Anxiety (HAMA);The Pittsburgh Sleep Quality Index (PSQI);The Nepean Dyspepsia Index-quality of life (NDI-QOL);

Countries

China

Contacts

Public ContactLin Jia
jialin@medmail.com.cn+86 13925012853

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026