Status:
NOT_YET_RECRUITING
Pilot Trial for Health Products in Psychological Distress and Insomnia
Lead Sponsor:
The University of Hong Kong
Conditions:
Psychological Distress
Insomnia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a pilot, single-site, two-armed, 16 weeks, double-blinded, randomized, placebo-controlled trial. A total of 60 patients aged 18-65 with psychological distress will be recruited. They will be r...
Detailed Description
Psychological distress is a state of emotional suffering characterized by a combination of undifferentiated symptoms ranging from anxiety (e.g., restlessness), depression (e.g., loss of interest), str...
Eligibility Criteria
Inclusion
- Subjects will be eligible for this study if they:
- are experiencing anxiety and/or depressive symptoms, as evidenced by a BAI-C score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63) and/or a C-BDI-II score of at least 14 (no symptoms = 0-13, mild = 14-19; moderate = 20-28; severe = 29-63), with symptoms persistent for more than 3 months; and
- are able to provide informed consent for participation, take medications and complete questionnaires as scheduled.
Exclusion
- Subjects will be excluded if they:
- have unstable systemic medical conditions that may limit their participation in the study (e.g., severe liver, cardiovascular or kidney impairment; gastrointestinal or endocrine dysfunction; malignancy; autoimmune disease or acute infectious disease);
- have bipolar disorder, psychotic disorder (e.g., schizophrenia), organic mental disorder (e.g., Alzheimer's disease), or significant cognitive impairment;
- present suicidal ideation (a score of ≥3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS);
- have a history of brain injury or surgery;
- have alcohol abuse or substance abuse;
- are pregnant or in lactation, or are intend to conceive;
- have use of herbal remedies in the previous 6 months;
- have a history of hypersensitivity to investigational drug treatment or the active or inactive constituents of the tested products;
- have treatment with brain stimulation in the previous 6 months; or
- are involved in other interventional clinical studies in the last 3 months or any relevant condition potentially interfering with study evaluation.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06579183
Start Date
June 1 2025
End Date
December 1 2028
Last Update
May 20 2025
Active Locations (1)
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1
The University of Hong Kong
Hong Kong, Hong Kong, 000000