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Bipolar Disorder (BPD)NCT07860957

Midday Bright Light Therapy for Bipolar Depression

A study testing Bright Light Therapy in people with Bipolar Disorder (BPD), run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized, double-blind, placebo-controlled study evaluated adjunctive midday bright light therapy in adults with bipolar I or II disorder experiencing mild-to-moderate depression. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder (BPD)
What is being tested?
Bright Light Therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Apr 2021to 11 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years.
  • Diagnosis of bipolar I or bipolar II disorder according to DSM-5 criteria.
  • Current mild-to-moderate depressive episode, defined as a 17-item Hamilton Depression Rating Scale (HAM-D-17) score of 8-18.
  • No hypomanic or mixed symptoms, defined as a Young Mania Rating Scale (YMRS) score ≤7.
  • Treatment with a mood stabilizer and/or an atypical antipsychotic at a stable dosage for at least 4 weeks before enrollment.

Who cannot join

  • Manic, hypomanic, or mixed episode within the preceding 6 months.
  • Active suicidal ideation.
  • Acute or chronic psychotic symptoms.
  • Substance use disorder within the preceding 6 months.
  • Chronic ophthalmological disease.
  • Use of medications that may cause photosensitivity.
  • Shift work.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

    Istanbul, 34098

  • Bakırköy Prof. Dr. Mazhar Osman Training and Research Hospital for Psychiatry, Neurology and Neurosurgery

    Istanbul, 34147

Other trials in Turkey (Türkiye)

About this study

Official title: Midday Bright Light Therapy for Bipolar Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

This randomized, double-blind, placebo-controlled study evaluated adjunctive midday bright light therapy in adults with bipolar I or II disorder experiencing mild-to-moderate depression. Participants received either 10,000-lux bright light or 1,500-lux placebo light at home for 30 minutes daily between 12:00 PM and 2:00 PM for four weeks while continuing unchanged pharmacological treatment. The primary outcome was remission at week 4, defined as a total score below 9 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version. Secondary outcomes included clinical status, psychosocial functioning, sleep quality, circadian characteristics, and adverse effects.

Read the detailed description

This randomized, double-blind, placebo-controlled study evaluated the efficacy of bright light therapy as an add-on treatment for adults with bipolar I or bipolar II disorder experiencing a mild-to-moderate depressive episode. The study examined whether bright light therapy improves depressive symptoms and also evaluated its effects on clinical status, psychosocial functioning, sleep quality, circadian characteristics, and treatment-emergent adverse effects.

Participants continued their existing mood stabilizer and/or atypical antipsychotic treatment at unchanged doses and were randomly assigned to receive either active bright light therapy (10,000 lux) or placebo light therapy (1,500 lux). Both groups used the same light therapy device at home for 30 minutes daily between 12:00 PM and 2:00 PM for four weeks. Clinical assessments were conducted before treatment and weekly throughout the four-week treatment period. The primary outcome was remission at the end of week 4, defined as the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version total score below 9.

Being tested
Bright Light Therapy, Placebo Light Therapy
Keywords
Bipolar Depression, Bright Light Therapy, Bipolar Disorder, Depressive Symptoms, Sleep Quality
Medical subject headings
Bipolar Disorder, Depression, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bright Light TherapyDevice

    Bright light therapy was administered using a Beurer TL100 daylight therapy lamp (Beurer, Ulm, Germany) set to deliver 10,000 lux. Participants used the device at home for 30 minutes daily between 12:00 PM and 2:00 PM for four weeks, at a distance of 10 cm from the device. Participants were instructed to keep their face turned toward the light box while avoiding direct and continuous gaze at the light source.

  • Placebo Light TherapyDevice

    Placebo light therapy was administered using the same Beurer TL100 daylight therapy lamp (Beurer, Ulm, Germany) set to deliver 1,500 lux. Participants used the device at home for 30 minutes daily between 12:00 PM and 2:00 PM for four weeks, at a distance of 10 cm from the device, following the same instructions as the active treatment group.

Study groups in NCT07860957
Study groupRoleWhat they receive
Active Bright Light TherapyExperimentalParticipants received active bright light therapy at 10,000 lux using a Beurer TL100 daylight therapy lamp for 30 minutes daily between 12:00 PM and 2:00 PM for four weeks. The light box was positioned directly facing the participant at a distance of 10 cm. Participants continued their existing pharmacological treatment at unchanged doses throughout the study.
Receives: Device: Bright Light Therapy
Placebo Light TherapyPlacebo comparatorParticipants assigned to this arm received placebo light therapy at 1,500 lux using the same Beurer TL100 daylight therapy lamp. The intervention was administered at home for 30 minutes daily between 12:00 PM and 2:00 PM for four weeks, in addition to participants' ongoing pharmacological treatment.
Receives: Device: Placebo Light Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission Rate Based on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version at Week 4

    Total scores range from 0 to 90, with higher scores indicating more severe depressive symptoms and a worse outcome.Remission was defined as a total score below 9 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version at the end of the fourth week of treatment.

    Measured: At the end of week 4

Secondary outcomes (9)
  1. Treatment Response Rate Based on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version

    Depressive symptoms were assessed using the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version, comprising 21 Hamilton Depression Rating Scale items and 8 additional items assessing atypical depressive symptoms. Total scores range from 0 to 90, with higher scores indicating more severe depressive symptoms and a worse outcome.Treatment response was defined as a reduction of at least 50% from baseline in the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version total score.

    Measured: From baseline to the end of week 4

  2. Change in Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version Total Score

    Depressive symptoms were assessed using the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version, comprising 21 Hamilton Depression Rating Scale items and 8 additional items assessing atypical depressive symptoms. Total scores range from 0 to 90, with higher scores indicating more severe depressive symptoms and a worse outcome.

    Measured: At baseline and at the end of weeks 1, 2, 3, and 4

  3. Clinical Global Impression Scores

    Overall clinical status was assessed using the Clinical Global Impression scale. The Severity and Improvement subscales each range from 1 to 7, with higher scores indicating greater illness severity and less improvement or greater worsening, respectively. Side effect severity scores range from 1 to 4, with higher scores indicating more severe side effects. Higher scores indicate worse outcomes.

    Measured: Severity was assessed at baseline and at the end of weeks 1, 2, 3, and 4; Improvement was assessed at the end of weeks 1, 2, 3, and 4.

  4. Global Assessment of Functioning Scores

    Psychosocial functioning was assessed using the Global Assessment of Functioning scale. Scores range from 1 to 100, with higher scores indicating better functioning and a better outcome. A score of 0 indicates insufficient information.

    Measured: At baseline and at the end of weeks 1, 2, 3, and 4

  5. Udvalg for Kliniske Undersøgelser Side Effect Rating Scale Scores (UKU)

    Treatment-emergent adverse effects were assessed using the Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale. The scale comprises 48 items, each scored from 0 (no side effect) to 3 (severe side effect). Total scores range from 0 to 144, with higher scores indicating more severe adverse effects and a worse outcome.

    Measured: At baseline and at the end of weeks 1, 2, 3, and 4

  6. Change in Young Mania Rating Scale Scores

    Manic and hypomanic symptoms were assessed using the Young Mania Rating Scale, an 11-item clinician-rated scale. Total scores range from 0 to 60, with higher scores indicating more severe manic symptoms and a worse outcome.

    Measured: At baseline and at the end of weeks 1, 2, 3, and 4

  7. Change in Beck Scale for Suicide Ideation Scores

    Suicidal ideation was assessed using the Beck Scale for Suicide Ideation. Total scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.

    Measured: At baseline and at the end of weeks 1, 2, 3, and 4

  8. Change in Pittsburgh Sleep Quality Index Scores

    Sleep quality was assessed using the Pittsburgh Sleep Quality Index, a self-report scale comprising seven components, each scored from 0 to 3. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality and greater sleep disturbance.

    Measured: At baseline and at the end of week 4

  9. Change in Morningness-Eveningness Stability Scale improved Subscale Scores

    Circadian rhythm characteristics were assessed using the Morningness-Eveningness Stability Scale improved (MESSi), a 15-item scale comprising three subscales: Morning Affect, Eveningness, and Distinctness. Each subscale score ranges from 5 to 25. Higher Morning Affect scores indicate greater morning alertness and energy; higher Eveningness scores indicate a stronger evening preference; and higher Distinctness scores indicate greater daily fluctuations in alertness and functioning. Higher scores do not uniformly indicate better or worse outcomes across the three subscales.

    Measured: At baseline and at the end of week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2026
  2. Study start1 Apr 2021
  3. Primary completion11 Jun 2026
  4. Study completion11 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07860957
Sponsor's protocol ID
5249
Status last verified
Oct 2026
First submitted
1 Oct 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wirz-Justice A, Graw P, Krauchi K, Gisin B, Jochum A, Arendt J, Fisch HU, Buddeberg C, Poldinger W. Light therapy in seasonal affective disorder is independent of time of day or circadian phase. Arch Gen Psychiatry. 1993 Dec;50(12):929-37. doi: 10.1001/archpsyc.1993.01820240013001.

    PubMed 8250678
  • Yorguner Kupeli N, Bulut NS, Carkaxhiu Bulut G, Kurt E, Kora K. Efficacy of bright light therapy in bipolar depression. Psychiatry Res. 2018 Feb;260:432-438. doi: 10.1016/j.psychres.2017.12.020. Epub 2017 Dec 12.

    PubMed 29268206
  • van Maanen A, Meijer AM, van der Heijden KB, Oort FJ. The effects of light therapy on sleep problems: A systematic review and meta-analysis. Sleep Med Rev. 2016 Oct;29:52-62. doi: 10.1016/j.smrv.2015.08.009. Epub 2015 Sep 9.

    PubMed 26606319
  • Sit DK, McGowan J, Wiltrout C, Diler RS, Dills JJ, Luther J, Yang A, Ciolino JD, Seltman H, Wisniewski SR, Terman M, Wisner KL. Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2018 Feb 1;175(2):131-139. doi: 10.1176/appi.ajp.2017.16101200. Epub 2017 Oct 3.

    PubMed 28969438

Questions about this trial

What is this clinical trial studying?

A study testing Bright Light Therapy in people with Bipolar Disorder (BPD), run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission Rate Based on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version at Week 4 (time frame: At the end of week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07860957, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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