Trials / Unknown
UnknownNCT04803071
Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression
Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression: a 12 Week Randomized, Double-blind, Placebo-controlled Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 288 (estimated)
- Sponsor
- Guangzhou Psychiatric Hospital · Other Government
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study was to evaluate the effect of n-3pufas on cognitive function in patients with depression
Detailed description
Depression is often accompanied by cognitive impairment. At present, there is no effective drug to improve the cognitive impairment in patients with depression, and the social function and quality of life of patients are affected in varying degrees. N-3 polyunsaturated fatty acids (n-3pufas) are food products with high safety and few adverse reactions. Previous clinical trials have also suggested that n-3pufas may help to improve cognitive impairment in patients with depression, but the reported results are different. We have developed a new generation of n-3pufas optimal proportion combination products and found good cognitive improvement effect in animal models of depression. Therefore, this clinical research project will screen out the depressive patients with cognitive impairment through the cognitive function battery test (MCCB) tool for schizophrenia. On the basis of routine treatment of depression, these patients will be added with the cognitive improvement formula n-3pufas capsule developed by us to explore the effect of n-3pufas formula on cognitive impairment of depression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Experimental group of n-pufas improving cognitive formula | Three times a day, one capsule of n-3pufas improvement cognitive formula capsule (once in the morning, in the evening) and routine treatment for depression, lasting for 12 weeks |
| DIETARY_SUPPLEMENT | General fish oil formula product adjuvant treatment control group | The control group: 1 capsule of general fish oil formula (once in the morning, in the evening) three times a day, plus routine treatment for depression, lasting for 12 weeks |
| DIETARY_SUPPLEMENT | Placebo assisted treatment group | Three times a day, one capsule of placebo adjuvant therapy (once in the morning, one in the evening) and conventional treatment of depression for 12 weeks |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2022-10-01
- Completion
- 2022-10-01
- First posted
- 2021-03-17
- Last updated
- 2021-03-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04803071. Inclusion in this directory is not an endorsement.