Depressive Symptoms Post Cardiac Surgery or Post Acute Coronary SyndromePhase 4BEAM-PNCT02621567
Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial
A Phase 4 study testing Bright Light Therapy Lamp and Modified Dim Lamp in people with Depressive Symptoms Post Cardiac Surgery or Post Acute Coronary Syndrome, run by McGill University at 1 site in Canada.
Trial summary
Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to assess the feasibility of conducting a full trial which would assess the efficacy of Bright Light Therapy (BLT) for improving depressive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms Post Cardiac Surgery or Post Acute Coronary Syndrome
- What is being tested?
- Bright Light Therapy Lamp and Modified Dim Lamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to 20 Oct 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing cardiac surgery or hospitalized for an acute coronary syndrome;
- Age ≥ 18 years;
- Score of ≥ 8 on the Patient Health Questionnaire-9;
- Able to understand and to provide informed consent in English or French; and
- Likely to be available for follow-up.
Who cannot join
- Pregnant or lactating females;
- Medical condition with a prognosis < 12 weeks;
- History of bipolar disorder, SAD, psychosis, or dementia;
- Medical condition contraindicating use of BLT (ocular or retinal pathology: glaucoma, cataracts, retinal detachment, retinopathy, diabetes);
- Medical condition that increases photosensitivity (e.g. systemic lupus erythematosus, rosacea, psoriasis, albinism);
- Current use of medication that increases photosensitivity (e.g. St John's Wort, lithium, melatonin, tetracycline, Accutane, Benzoyl peroxide, Retin-A);
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- Less than one month following previous BLT;
- Light induced epilepsy or migraines; or
- Suicidal ideation.
Trial locations and contacts
1 site in 1 country.
About this study
Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to assess the feasibility of conducting a full trial which would assess the efficacy of Bright Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary syndrome.
Read the detailed description
Overall Study Objective
The Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to assess the feasibility of conducting a full trial which would assess the efficacy of Bright Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary syndrome (ACS).
Specific Objectives
To assess the feasibility of conducting a full trial, including assessment of recruitment rate, retention rate, adherence, process time, and potential additional data values that should be measured.
Rationale
More than 50,000 Canadians undergo coronary artery bypass grafting (the most common cardiac surgery) each year and over 100,000 are hospitalized for an ACS. Of these patients, at least 15-20% experience depression. Depressed cardiac patients have a nearly 20% increased risk of all-cause mortality, increased risk of cardiac death, and increased risk of experiencing future cardiovascular events. Addressing depression and depressive symptoms in cardiac surgery and ACS patients is therefore crucial. BLT could represent a simple, safe, and cost-effective method of reducing depressive symptoms following cardiac surgery or ACS. BLT has been shown to decrease depressive symptoms in individuals with both seasonal affective disorder and non-seasonal depression in the general population, as well as in a few specific patient populations. However, the efficacy of BLT for reducing depressive symptoms post-cardiac surgery or ACS is unknown. The full BEAM Trial will be the first to study the effects of BLT in this patient population. Since BLT has not yet been investigated in cardiac patients, the feasibility of conducting a large trial of BLT in this population must be determined in order to avoid potential pitfalls and enhance the chances of success of a full trial.
Methods
We will conduct an RCT with a treatment period of 4 weeks and 12 week follow-up post-cardiac surgery or ACS. A total of 38 cardiac surgery or ACS participants will be randomized 1:1 to one of two treatment arms: 1) BLT (10,000 lux light intensity) or 2) Dim light (control group; 500 lux light intensity). Study personnel and participants will be blinded as to treatment allocation. Permutated block randomization will help ensure a balance of known and unknown confounders. Informed consent will be obtained in person from all individuals. Participants in both groups will begin using the lamps in-hospital and will continue the treatment at home for the remainder of the 4 weeks post-surgery or ACS. At baseline and day of discharge, participants will complete the Patient Health Questionnaire 9 (PHQ-9), Depression Anxiety Stress Scale short version (DASS-21), and Short Form (36) Health Survey (SF-36) questionnaires in order to determine index levels of depressive symptomology (PHQ-9, DASS-21) and health-related quality of life (SF-36). A case report form, to collect demographic and clinical information, will also be completed at baseline and day of discharge. There will be a clinic visit at week 4, when patients will return their lamp and complete questionnaires, and study personnel will complete a case report form to monitor treatment adherence. At week 12, participants will have the option to complete their questionnaires online or by mail. To compensate participants for expenses incurred due to participation (parking, childcare, opportunity costs, etc.), they will receive $25 at week 4, and a $20 prepaid VISA card after completing the questionnaires at week 12.
Significance
BLT may be a simple, cost-effective, and safe method of decreasing the severity of depression and depressive symptoms in patients following cardiac surgery or ACS. Even a small reduction in depressive symptoms could have a significant effect on the occurrence of cardiovascular events, cardiac death, and all-cause mortality in this high-risk population. The full BEAM Trial will provide regulators, health care professionals, and patients with important new information about the efficacy of BLT to decrease symptoms of depression in this population. Conducting the BEAM-P study will help ensure the success of carrying out the full BEAM Trial.
- Being tested
- Bright Light Therapy Lamp, Modified Dim Lamp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light Therapy LampDevice
TRAVelite Desk Lamp manufactured by Northern Light Technologies, located in Montreal, Quebec. The light is emitted from a lamp. The florescent tubes in the box are covered with a diffusing screen to ensure even distribution of light and protection from ultraviolet light. These lamps also have a stand which enables users to place the box horizontally or vertically on most surfaces. These lamps emit light of intensity 10,000 lux.
Modified Dim LampDevice
TRAVelite Desk Lamp manufactured by Northern Light Technologies, located in Montreal, Quebec. The light is emitted from a lamp. The florescent tubes in the box are covered with a diffusing screen to ensure even distribution of light and protection from ultraviolet light. These lamps also have a stand which enables users to place the box horizontally or vertically on most surfaces. These lamps have been modified to emit light of intensity 500 lux.
| Study group | Role | What they receive |
|---|---|---|
| Bright Light Therapy Group | Experimental | Participants in this group will receive bright light therapy lamps and will be instructed to use them for 30 minutes every morning within an hour of waking up, everyday for 4 weeks. Receives: Device: Bright Light Therapy Lamp |
| Dim Light Group | Placebo comparator | Participants in this group will receive modified dim lamps and will be instructed to use them for 30 minutes every morning within an hour of waking up, everyday for 4 weeks. Receives: Device: Modified Dim Lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Measured: Baseline
Secondary outcomes (2)
Retention rate
Percentage of participants who remain in the study at week 12
Measured: 12 week follow-up period
Adherence rate
Percentage of participants who used their lamp on ≥60% of mornings within an hour of waking for at least 25 minutes throughout the 4 week treatment period
Measured: 4 week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Depressive Symptoms Post Cardiac Surgery or Post Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Eisenberg, McGill University
- Investigators
- Mark J Eisenberg, Principal investigator, McGill University, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621567
- Sponsor's protocol ID
- 15-125
- Acronym
- BEAM-P
- Status last verified
- Mar 2018
- First submitted
- 27 Nov 2015
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Huffman JC, Celano CM, Beach SR, Motiwala SR, Januzzi JL. Depression and cardiac disease: epidemiology, mechanisms, and diagnosis. Cardiovasc Psychiatry Neurol. 2013;2013:695925. doi: 10.1155/2013/695925. Epub 2013 Apr 7.
PubMed 23653854Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221.
PubMed 22916068Pincus HA, Pettit AR. The societal costs of chronic major depression. J Clin Psychiatry. 2001;62 Suppl 6:5-9.
PubMed 11310818Stewart WF, Ricci JA, Chee E, Hahn SR, Morganstein D. Cost of lost productive work time among US workers with depression. JAMA. 2003 Jun 18;289(23):3135-44. doi: 10.1001/jama.289.23.3135.
PubMed 12813119Frasure-Smith N, Lesperance F, Gravel G, Masson A, Juneau M, Talajic M, Bourassa MG. Depression and health-care costs during the first year following myocardial infarction. J Psychosom Res. 2000 Apr-May;48(4-5):471-8. doi: 10.1016/s0022-3999(99)00088-4.
PubMed 10880668Blumenthal JA. Depression and coronary heart disease: association and implications for treatment. Cleve Clin J Med. 2008 Mar;75 Suppl 2:S48-53. doi: 10.3949/ccjm.75.suppl_2.s48.
PubMed 18540147Frasure-Smith N, Lesperance F, Talajic M. Depression and 18-month prognosis after myocardial infarction. Circulation. 1995 Feb 15;91(4):999-1005. doi: 10.1161/01.cir.91.4.999.
PubMed 7531624Bush DE, Ziegelstein RC, Tayback M, Richter D, Stevens S, Zahalsky H, Fauerbach JA. Even minimal symptoms of depression increase mortality risk after acute myocardial infarction. Am J Cardiol. 2001 Aug 15;88(4):337-41. doi: 10.1016/s0002-9149(01)01675-7.
PubMed 11545750Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, Nemeroff CB. The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62. doi: 10.1176/appi.ajp.162.4.656.
PubMed 15800134Lieverse R, Van Someren EJ, Nielen MM, Uitdehaag BM, Smit JH, Hoogendijk WJ. Bright light treatment in elderly patients with nonseasonal major depressive disorder: a randomized placebo-controlled trial. Arch Gen Psychiatry. 2011 Jan;68(1):61-70. doi: 10.1001/archgenpsychiatry.2010.183.
PubMed 21199966Tuunainen A, Kripke DF, Endo T. Light therapy for non-seasonal depression. Cochrane Database Syst Rev. 2004;2004(2):CD004050. doi: 10.1002/14651858.CD004050.pub2.
PubMed 15106233Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. doi: 10.1016/s0165-0327(98)00005-6.
PubMed 9609674Niederhofer H, von Klitzing K. Bright light treatment as mono-therapy of non-seasonal depression for 28 adolescents. Int J Psychiatry Clin Pract. 2012 Sep;16(3):233-7. doi: 10.3109/13651501.2011.625123. Epub 2012 Jul 19.
PubMed 22809107Wirz-Justice A, Bader A, Frisch U, Stieglitz RD, Alder J, Bitzer J, Hosli I, Jazbec S, Benedetti F, Terman M, Wisner KL, Riecher-Rossler A. A randomized, double-blind, placebo-controlled study of light therapy for antepartum depression. J Clin Psychiatry. 2011 Jul;72(7):986-93. doi: 10.4088/JCP.10m06188blu. Epub 2011 Apr 5.
PubMed 21535997Baxendale S, O'Sullivan J, Heaney D. Bright light therapy for symptoms of anxiety and depression in focal epilepsy: randomised controlled trial. Br J Psychiatry. 2013 May;202(5):352-6. doi: 10.1192/bjp.bp.112.122119. Epub 2013 Mar 21.
PubMed 23520221
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial
- ClinicalTrials.gov ID
- NCT02621567
- Acronym / sponsor ID
- BEAM-P / 15-125
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to assess the feasibility of conducting a full trial which would assess the efficacy of Bright Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary syndrome.
Detailed description
Overall Study Objective
The Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to assess the feasibility of conducting a full trial which would assess the efficacy of Bright Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary syndrome (ACS).
Specific Objectives
To assess the feasibility of conducting a full trial, including assessment of recruitment rate, retention rate, adherence, process time, and potential additional data values that should be measured.
Rationale
More than 50,000 Canadians undergo coronary artery bypass grafting (the most common cardiac surgery) each year and over 100,000 are hospitalized for an ACS. Of these patients, at least 15-20% experience depression. Depressed cardiac patients have a nearly 20% increased risk of all-cause mortality, increased risk of cardiac death, and increased risk of experiencing future cardiovascular events. Addressing depression and depressive symptoms in cardiac surgery and ACS patients is therefore crucial. BLT could represent a simple, safe, and cost-effective method of reducing depressive symptoms following cardiac surgery or ACS. BLT has been shown to decrease depressive symptoms in individuals with both seasonal affective disorder and non-seasonal depression in the general population, as well as in a few specific patient populations. However, the efficacy of BLT for reducing depressive symptoms post-cardiac surgery or ACS is unknown. The full BEAM Trial will be the first to study the effects of BLT in this patient population. Since BLT has not yet been investigated in cardiac patients, the feasibility of conducting a large trial of BLT in this population must be determined in order to avoid potential pitfalls and enhance the chances of success of a full trial.
Methods
We will conduct an RCT with a treatment period of 4 weeks and 12 week follow-up post-cardiac surgery or ACS. A total of 38 cardiac surgery or ACS participants will be randomized 1:1 to one of two treatment arms: 1) BLT (10,000 lux light intensity) or 2) Dim light (control group; 500 lux light intensity). Study personnel and participants will be blinded as to treatment allocation. Permutated block randomization will help ensure a balance of known and unknown confounders. Informed consent will be obtained in person from all individuals. Participants in both groups will begin using the lamps in-hospital and will continue the treatment at home for the remainder of the 4 weeks post-surgery or ACS. At baseline and day of discharge, participants will complete the Patient Health Questionnaire 9 (PHQ-9), Depression Anxiety Stress Scale short version (DASS-21), and Short Form (36) Health Survey (SF-36) questionnaires in order to determine index levels of depressive symptomology (PHQ-9, DASS-21) and health-related quality of life (SF-36). A case report form, to collect demographic and clinical information, will also be completed at baseline and day of discharge. There will be a clinic visit at week 4, when patients will return their lamp and complete questionnaires, and study personnel will complete a case report form to monitor treatment adherence. At week 12, participants will have the option to complete their questionnaires online or by mail. To compensate participants for expenses incurred due to participation (parking, childcare, opportunity costs, etc.), they will receive $25 at week 4, and a $20 prepaid VISA card after completing the questionnaires at week 12.
Significance
BLT may be a simple, cost-effective, and safe method of decreasing the severity of depression and depressive symptoms in patients following cardiac surgery or ACS. Even a small reduction in depressive symptoms could have a significant effect on the occurrence of cardiovascular events, cardiac death, and all-cause mortality in this high-risk population. The full BEAM Trial will provide regulators, health care professionals, and patients with important new information about the efficacy of BLT to decrease symptoms of depression in this population. Conducting the BEAM-P study will help ensure the success of carrying out the full BEAM Trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright Light Therapy Group | Experimental | Device: Bright Light Therapy LampParticipants in this group will receive bright light therapy lamps and will be instructed to use them for 30 minutes every morning within an hour of waking up, everyday for 4 weeks. |
| Dim Light Group | Placebo comparator | Device: Modified Dim LampParticipants in this group will receive modified dim lamps and will be instructed to use them for 30 minutes every morning within an hour of waking up, everyday for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing cardiac surgery or hospitalized for an acute coronary syndrome;
- Age ≥ 18 years;
- Score of ≥ 8 on the Patient Health Questionnaire-9;
- Able to understand and to provide informed consent in English or French; and
- Likely to be available for follow-up.
Key exclusion criteria (9 listed)
- Pregnant or lactating females;
- Medical condition with a prognosis < 12 weeks;
- History of bipolar disorder, SAD, psychosis, or dementia;
- Medical condition contraindicating use of BLT (ocular or retinal pathology: glaucoma, cataracts, retinal detachment, retinopathy, diabetes);
- Medical condition that increases photosensitivity (e.g. systemic lupus erythematosus, rosacea, psoriasis, albinism);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light Therapy LampTRAVelite Desk Lamp manufactured by Northern Light Technologies, located in Montreal, Quebec. The light is emitted from a lamp. The florescent tubes in the box are covered with a diffusing screen to ensure even distribution of light and protection from ultraviolet light. These lamps also have a stand which enables users to place the box horizontally or vertically on most surfaces. These lamps emit light of intensity 10,000 lux. | Device | Bright Light Therapy Group |
| Modified Dim LampTRAVelite Desk Lamp manufactured by Northern Light Technologies, located in Montreal, Quebec. The light is emitted from a lamp. The florescent tubes in the box are covered with a diffusing screen to ensure even distribution of light and protection from ultraviolet light. These lamps also have a stand which enables users to place the box horizontally or vertically on most surfaces. These lamps have been modified to emit light of intensity 500 lux. | Device | Dim Light Group |
Primary outcome
Recruitment rate
Time frame: Baseline
2 secondary outcomes
Retention rate
Time frame: 12 week follow-up period
Adherence rate
Time frame: 4 week follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Background: PubMed 23653854Huffman JC, Celano CM, Beach SR, Motiwala SR, Januzzi JL. Depression and cardiac disease: epidemiology, mechanisms, and diagnosis. Cardiovasc Psychiatry Neurol. 2013;2013:695925. doi: 10.1155/2013/695925. Epub 2013 Apr 7.
- Background: PubMed 22916068Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221.
- Background: PubMed 11310818Pincus HA, Pettit AR. The societal costs of chronic major depression. J Clin Psychiatry. 2001;62 Suppl 6:5-9.
- Background: PubMed 12813119Stewart WF, Ricci JA, Chee E, Hahn SR, Morganstein D. Cost of lost productive work time among US workers with depression. JAMA. 2003 Jun 18;289(23):3135-44. doi: 10.1001/jama.289.23.3135.
- Background: PubMed 10880668Frasure-Smith N, Lesperance F, Gravel G, Masson A, Juneau M, Talajic M, Bourassa MG. Depression and health-care costs during the first year following myocardial infarction. J Psychosom Res. 2000 Apr-May;48(4-5):471-8. doi: 10.1016/s0022-3999(99)00088-4.
- Background: PubMed 18540147Blumenthal JA. Depression and coronary heart disease: association and implications for treatment. Cleve Clin J Med. 2008 Mar;75 Suppl 2:S48-53. doi: 10.3949/ccjm.75.suppl_2.s48.
- Background: PubMed 7531624Frasure-Smith N, Lesperance F, Talajic M. Depression and 18-month prognosis after myocardial infarction. Circulation. 1995 Feb 15;91(4):999-1005. doi: 10.1161/01.cir.91.4.999.
- Background: PubMed 11545750Bush DE, Ziegelstein RC, Tayback M, Richter D, Stevens S, Zahalsky H, Fauerbach JA. Even minimal symptoms of depression increase mortality risk after acute myocardial infarction. Am J Cardiol. 2001 Aug 15;88(4):337-41. doi: 10.1016/s0002-9149(01)01675-7.
- Background: PubMed 15800134Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, Nemeroff CB. The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62. doi: 10.1176/appi.ajp.162.4.656.
- Background: PubMed 21199966Lieverse R, Van Someren EJ, Nielen MM, Uitdehaag BM, Smit JH, Hoogendijk WJ. Bright light treatment in elderly patients with nonseasonal major depressive disorder: a randomized placebo-controlled trial. Arch Gen Psychiatry. 2011 Jan;68(1):61-70. doi: 10.1001/archgenpsychiatry.2010.183.
- Background: PubMed 15106233Tuunainen A, Kripke DF, Endo T. Light therapy for non-seasonal depression. Cochrane Database Syst Rev. 2004;2004(2):CD004050. doi: 10.1002/14651858.CD004050.pub2.
- Background: PubMed 9609674Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. doi: 10.1016/s0165-0327(98)00005-6.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J Eisenberg principal investigator
McGill University, Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bright Light Therapy Lamp and Modified Dim Lamp in people with Depressive Symptoms Post Cardiac Surgery or Post Acute Coronary Syndrome, run by McGill University at 1 site in Canada.
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 9 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recruitment rate (time frame: Baseline). 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 NCT02621567, which also lists 22 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 22 Mar 2018.