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Multi-nutrient supplements for improvement of fatigue symptoms in acute depression: a randomized, double-blind, placebo-controlled trial

Multi-nutrient supplements for improvement of fatigue symptoms in acute depression: a randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076906
Enrollment
Unknown
Registered
2023-10-24
Start date
2023-03-29
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Depression

Interventions

Experimental group:Comprehensive nutrient+ SSRI
Control group:Starch+ SSRI

Sponsors

Beijing AnDing Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: A. Out-patient aged 18-65 years (including 18 and 65 years), regardless of gender; B. Meet the Diagnostic criteria for major depressive disorder (MINI diagnosis) of the American Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV), first episode or relapse, without psychotic symptoms; C. This attack has not been systematically treated with antidepressants or the cumulative use of antidepressants in the last 14 days has not exceeded 7 days; D. The patient plans to be treated with a single SSRI antidepressant; E. During screening, the total score of QIDS-SR16 =11, the total score of HAMD-17 =14 and the FSS score greater than or equal to 36; F. Primary school education or above, able to understand the content of the scale; G. Informed consent signed by the patient.

Exclusion criteria

Exclusion criteria: A. Previous well-defined episodes of mania or hypomania; B. Previously diagnosed patients with bipolar disorder, schizophrenia, schizoaffective disorder and mental disorders associated with other diseases; C. Patients with a history of alcohol dependence and acute intoxication; D. Pregnant or lactating female patients; E. Currently, researchers with serious physical diseases do not consider it suitable to be included in this study; F. For patients considered by the researchers to be currently at serious risk of suicide, the HAMD-17 suicide risk entry was greater than or equal to 3 points

Design outcomes

Primary

MeasureTime frame
Subtraction value of FSS scale;

Secondary

MeasureTime frame
Subtraction value of HAMD-17 scale;Study endpoint HAMD-17 reduction rate and remission rate;Study endpoint QIDS-16 reduction rate and remission rate;Subtraction value of QIDS-16 scale;Subtraction value of PSQI scale;Subtraction value of SDS scale;Subtraction value of Q-LES-Q-SF scale;Changes of inflammatory factors, intestinal microbes and other related indicators;

Countries

China

Contacts

Public ContactRuinan Li

Beijing AnDing Hospital, Capital Medical University

lrn0509@163.com+86 136 8362 2730

Outcome results

None listed

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