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NCT06443242Not yet recruiting

Efficacy and Safety of Low-dose Laser Acupuncture on Treating Insomnia Associated With Major Depressive Disorder

Efficacy and Safety of Low-dose Laser Acupuncture on Treating Insomnia Associated With Major Depressive Disorder: A Randomised Controlled Trial

Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this randomized controlled trial is to assess the efficacy and safety of low-dose laser acupuncture (LLA) in alleviating insomnia symptoms among patients suffering from major depressive disorder. The study seeks to answer the following questions: 1. How effective is LLA in alleviating insomnia symptoms as compare with SLA and control subjects among patients with major depressive disorder across pre-treatment, mid-treatment and post-treatment assessment? 2. How effective is LLA in alleviating depression symptoms as compare with SLA and control subjects among patients with major depressive disorder across pre-treatment, post-treatment and follow-up assessment? 3. What role do CORT and 5-HT play in the co-occurrence and progression of insomnia and major depressive disorder, and how does LLA act on these mechanisms to provide relief? 4. How does the safety and acceptability of LLA compare to traditional acupuncture in terms of eliminating discomfort and potential side effects? Researchers will compare the effects of LLA with sham laser acupuncture (SLA) and standard medication treatments to evaluate its efficacy and safety. Participants involved in this study will: Undergo 30 treatment sessions with LLA or SLA, five times a week for six weeks. Continue their usual pharmacological treatments for major depressive disorder. Participants will undergo comprehensive assessments at key points: pre-treatment, immediately post-treatment, and 12 weeks post-treatment. These evaluations will measure sleep quality and severity of insomnia indices, levels of depression and anxiety, and blood levels of CORT and 5-HT to assess the impact of LLA on insomnia symptoms and biochemical markers. Additionally, participant acceptance and the safety of the treatment will be monitored, including recording any adverse events and medication usage, to determine the effectiveness and safety of LLA in treating insomnia associated with major depressive disorder. By focusing on these elements, the study aims to provide clear, actionable insights into the benefits and risks of LLA as a treatment option for insomnia associated with major depressive disorder, enhancing the current treatment landscape and patient outcomes.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
13 May 2024
Start date
1 Dec 2025
Primary completion date
31 Aug 2027
Lead sponsor
Mohammad Farris Iman Leong Bin Abdullah
Diseases
Depression
NCT number
NCT06443242

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 1 Dec 2025 to the primary completion date, 31 Aug 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Individuals previously diagnosed with schizophrenia, bipolar disorder, or other psychiatric disorders;
  • Individuals with severe alcohol or drug abuse issues;

Other illness

  • Individuals with liver or kidney dysfunction, or with uncontrollable tumors or significant cerebrovascular diseases;

Other

  • Individuals with a marked tendency towards suicide, as assessed by a specialist;
  • Women who are pregnant or breastfeeding;
  • Individuals likely to have poor compliance or who are fearful of acupuncture treatment.

Who the study is looking for

  • Inpatients with a diagnosis of major depressive disorder (diagnosed according to the relevant diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders-V).
  • Male or female, 18 to 60 years of age.
  • Participants complaining of insomnia at initial screening.
  • PSQI score over 7.
  • HAMD score between 20 and 35.
  • No use of hypnotic medication or acupuncture treatment within the last month.
  • No cognitive or communication disorders.
  • Willingness to accept random group assignment and sign an informed consent form.
  • Those who have been on stable dose of antidepressant for at least the most recent two weeks and willing to maintain on the same dosage throughout the study.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

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This page is information, not medical advice. Discuss any trial with your doctor.