An interventional study of Experimental group of n-pufas improving cognitive formula and General fish oil formula product adjuvant treatment control group in Cognitive Impairment and Depression, sponsored by Guangzhou Psychiatric Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Guangzhou Psychiatric Hospital · Not applicable, Interventional, and Treatment
Among 309 studies in Cognitive Dysfunction with a site in China — 143 open to participants now, 155 under way, 8 of them phase 3. Cognitive Dysfunction · China.
Among the 309 studies in Cognitive Dysfunction with a site in China, this one is the 38th largest by planned enrollment of the 190 interventional ones, is one of 24 that started in 2020, is one of 138 with no phase, and was the 100th registered.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 288 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →143 of the 309 studies in Cognitive Dysfunction with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →309 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 24 started in 2020.
Median enrollment 110 across the 190 interventional studies, 300 across the 119 observational. Of the 90 that completed or were terminated, 3 (3%) have results posted.
16 of 309 have an industry lead sponsor. The 10 most frequent:
Guangzhou Psychiatric Hospital is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Guangzhou Psychiatric Hospital has 2 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
36 of the studies in Cognitive Dysfunction with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT07603102Nanjing Mingzhou Rehabilitation HospitalMindfulness With Dual-Task Training in Post-Stroke Mild Cognitive Impairment | 2026-11 |
| NCT06813274Hejiang YeMulticenter RCT of Eye-Brain Imaging in Diabetes Neurovascular Coupling | 2026-11-01 |
| NCT06090682Tianjin Huanhu HospitalEffect and Mechanism of Brain Stimulation for Parkinson's Disease With Cognitive Impairment | 2026-11-01 |
| NCT06417086ZhanYJClinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers | 2026-11-30 |
Among the 309 studies in Cognitive Dysfunction with a site in China, from their registry updates:
The aim of this study was to evaluate the effect of n-3pufas on cognitive function in patients with depression
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.
Inclusion Criteria:① the patients met the diagnostic criteria of dsm-5 major depressive disorder; ② aged 18-55 years; ③ Hamilton Depression Scale score of 24 items ≥ 20 points; YMRS score \< 6 points; ④ the score of wms-ii spatial span (assessment of working memory) in MCCB tool was less than or equal to its mean half standard deviation; ⑤ antidepressant types had not been adjusted in recent 2 weeks; 6) right handedness; 7) primary school had no change in the types of antidepressants The patients or their family members are willing to participate in the study and sign the .
Exclusion Criteria:① Merge with any other mental disorder; ② Patients with history of brain organic disease or traumatic brain injury and physical diseases; ③ abusers of drugs, alcohol or other psychoactive substances; ④ pregnant, lactating women and postpartum women; ⑤ depression; ⑥ severe suicide risk (c-ssrs assessment); ⑦ MECT treatment in recent three months; ③ continuous use of diazepam drugs in recent three months; Ⅸ long-term use of npufas in recent three months; ⑩ Long term use of anti-inflammatory drugs in the past three months.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
N-3pufas improved cognitive formula adjuvant therapy intervention group
Dietary Supplement: Experimental group of n-pufas improving cognitive formula
General fish oil formula product adjuvant treatment control group
Dietary Supplement: General fish oil formula product adjuvant treatment control group
Dietary Supplement: Placebo assisted treatment group
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
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
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
General information
Including gender, age, nationality, marriage, occupation, education level, education years, physical history, drug allergy history, tobacco and alcohol use.
Time frame: At baseline
Clinical data
Including the age of the first onset, the total course of disease, the course of the disease, the number of attacks, past medical history, family history, suicide and self injury.
Time frame: At baseline
Cognitive function assessment
Six cognitive dimensions, including processing speed, attention, working memory, language learning and memory, visual learning and memory, and executive function, were assessed by using standardized set of computer cognitive test (MCCB) based on MCCB, together with TONI-3 and tower of London (tower of London).
Time frame: At baseline, at the end of the 4th, 8th and 12th week
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2020 (actual). Primary completion is estimated for Oct 2022, 24 months after the start.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 24 months is below that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Guangzhou Psychiatric Hospital