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NCT Number: NCT05357313

Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

This is a randomized placebo-controlled trial to examine the efficacy of six-week bright light therapy as adjunctive treatment for patient with bipolar depression and eveningness.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

About this study

This randomized placebo-controlled trial aims to evaluate the efficacy of adjunctive BLT in addition to their maintenance treatment in reducing depressive symptoms. The second aim of the study is to explore the effects of BLT on sleep-wake changes and the sleep disturbances.

Method: Each eligible participant will be randomized to either i) bright light therapy (BLT) or ii) inactive negative ion generator (placebo) treatment for 30-minutes daily at the midday for a total of six weeks. Participants will be evaluated at baseline, 2nd, 4th and 6th week for depression and insomnia symptoms. Actigraphy will be done at baseline and in the last week of treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-65 years.
  • Is capable to give informed consent.
  • Meeting the diagnostic criteria of bipolar depression (including both bipolar I and II disorders) by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), Disorders (SCID-V).
  • a score 20 or above representing current moderate or severe episode of major depression and a score of at least 1 on items H1 or H2 on the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS), corresponding to at least moderate severity.
  • A score of 41 or less by the Morningness-Eveningness Questionnaire which represents eveningness.
  • On a stable dose of antimanic treatment for bipolar disorder for at least four weeks.

Exclusion criteria

  • Major Depressive Disorder fulfilling the Seasonal Pattern Specifier of the DSM-V (Seasonal Affective Disorder).
  • A past history of rapid-cycling within the past twelve months or a Young Mania Rating Scale more than 12 at screening
  • A current or past history of schizophrenia, mental retardation, organic mental disorder; or current substance use disorder.
  • Presence of psychotic symptoms or substantial suicidal risk as judged by the clinician and/or screening instruments.
  • Presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications such as St. John's wart; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma, and photosensitive skin condition e.g. systemic lupus erythematosus
  • Significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview.
  • Regular shift-workers or trans-meridian flight in the past 3 months or during study
  • Enrolment in another clinical trial of an investigational medicinal product or device.
  • Receiving regular psychotherapy.

Treatment and study plan

Bright Light Therapy

Device

Exposure to 10,000lux bright light for 30minutes a day for six weeks

Inactive negative ion generator

Device

Exposure to an inactive negative ion generator for 30 minutes a day for six weeks

Primary outcomes

  1. Change of depressive symptoms score

    Time frame: at the end of treatment

    Change in the score of the Structural Interview Guide for the Hamilton Depression Rating Scale with atypical depression supplement (SIGH-ADS), SIGH-ADS scores range from 0-79; higher score indicates greater depression severity.

Secondary outcomes

  1. Change of insomnia symptoms

    Time frame: at the end of treatment

    The change in the score of the Insomnia Severity Index (ISI), which ranges from 0-28, higher score indicates higher severity of insomnia

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

A Randomized Placebo-controlled Trial for Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 2, 2022
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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