Bipolar Type II DisorderBPII-DEP-LTNCT00590265
Light-Therapy in the Treatment of the Acute Phase of the Bipolar Type II Depression
A study testing Northern Light Technology (SADelite lamp) bright light-therapy and Northern Light Technology (SADelite lamp) Dim light-therapy in people with Bipolar Type II Disorder and Depression, Bipolar, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of light therapy for the treatment of bipolar type II patients relapsing into a depressive phase during autumn or winter. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Type II Disorder, Depression, Bipolar
- What is being tested?
- Northern Light Technology (SADelite lamp) bright light-therapy and Northern Light Technology (SADelite lamp) Dim light-therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to 27 Oct 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bipolar type II disorder, depressive phase meeting DSM-IV criteria as per the SCID interview
- Hamilton Depression Rating Scale 21 items (HAMD-21) ≥ 17 and a Montgomery Asberg rating Scale (MADRS) ≥ 15 for at least 2 weeks and the episode has begun during the month of september or a later month
- Able to give their consent and willingness to participate to the study
Who cannot join
- Other psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, diabetes, cardiac condition, hypertension
- Deficit in vitamin B12 or folate
- Sub-syndromic hypomania symptoms as per a Young Mania Rating Scale (YMRS) score ≥ 4
- History of manic or hypomanic switch when exposed to bright light or during prolonged exposure to the sun during previous depressive phases
- Pregnancy or absence of a contraceptive treatment
- History of light-induced migraine or epilepsy
Show all 12Show fewer
- Marked suicidal ideation
- Retinal blindness or severe cataract
- Glaucoma, retinal diseases of the eye
- Alcohol or drug abuse
- Known skin sensitivity to sunlight, especially in patients receiving photosensitizing drugs such as lithium or phenothiazines
- Past history of light therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
About this study
Official title: Light-Therapy in the Treatment of the Acute Phase of the Bipolar Type II Depression: Double-Blind, Placebo-Controlled Study to Establish Efficacy and Safety
The purpose of this study is to evaluate the efficacy and safety of light therapy for the treatment of bipolar type II patients relapsing into a depressive phase during autumn or winter.
Read the detailed description
Bipolar type II depression is a very frequent condition for which we still have a significant lack of acute treatments. There is now consistent evidence that light-therapy treatment produced a significant decrease of depressive symptoms for seasonal and non-seasonal unipolar depression. But there are no long-term studies of light therapy for the treatment of non-seasonal unipolar depression. It is also important to note that many of these studies involved co-therapy with antidepressant drugs or sleep-deprivation, making the interpretation of the results even more difficult.
Therefore, we propose to study the efficacy and safety of light therapy for the treatment of bipolar type II patients relapsing into a depressive phase during the period of September to mid-March. This will be a double-blind randomized placebo-controlled study. Bipolar II out-patients will be recruited from our bipolar disorders program and from our 5 general psychiatry out-patient clinics. We will recruit bipolar type II patients facing a depressive phase and after they give their informed consent and we had verified they meet all inclusion and exclusion criteria, they will be randomized blindly to Bright-light (10 000 lux) vs Dim-light placebo (100 lux) therapies. Both, patient and investigator/rater will be blind to the type of light treatment assigned to the patient. The light therapy will take place during 30 minutes daily in the morning AFTER the usual awakening time of the patient in order to avoid even partial sleep deprivation which would confound the results if we were to observe a greater switch rate into mania or hypomania.
Reasons for study termination can be serious side-effects, development of suicidal ideations or hypomanic/manic symptoms, patient's own decision, or any other of the exclusion criteria being fulfilled during the course of the study.
Depressive and manic/hypomanic symptoms, quality of life, sleep quality and side-effects will be assessed at baseline and during the study. Biological parameters will also be measured along the study. We think that this study will allow us to determine the efficacy and safety of a 5 weeks bright light therapy for Bipolar type II depression and provide open label data as to the long term benefits of this treatment if prolonged over 5 weeks during the "dark" months of the year.
- Conditions
- Bipolar Type II Disorder, Depression, Bipolar
- Being tested
- Northern Light Technology (SADelite lamp) bright light-therapy, Northern Light Technology (SADelite lamp) Dim light-therapy
- Keywords
- bipolar type II disorder, depression, remission, light-therapy, efficacy, safety
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Northern Light Technology (SADelite lamp) bright light-therapyDevice
Also called Northern Light Technology (SADelite lamp) with two 36W bulbs
10 000 lux for 30 minutes
Northern Light Technology (SADelite lamp) Dim light-therapyDevice
Also called Northern Light Technology (SADelite lamp) with two 18W bulbs + red filter (Medium Red 27 High Temperature treated, LEE Filters, Y = 3.64%)
<100 lux for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Northern Light Technology (SADelite lamp) bright light-therapy |
| 2 | Placebo comparator | Not described Receives: Device: Northern Light Technology (SADelite lamp) Dim light-therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the response rate as defined by a 50% improvement of the depressive symptoms score on the MADRS scale
Measured: 5 and 45 weeks
Secondary outcomes (5)
the remission rate (MADRS scale ≤ 8 )
Measured: 5 and 45 weeks
the relapse rate into depression or hypomania
Measured: 5 and 45 weeks
the sleep quality as per PSQI scale
Measured: 5 and 45 weeks
the quality of life as per SF-36 and Q-LES-Q SF scales
Measured: 5 and 45 weeks
the incidence of side-effects as per the UKU scale
Measured: 5 and 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJan 2008
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Bipolar Type II DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, Serge Beaulieu, Douglas Mental Health University Institute
- Investigators
- Serge Beaulieu, Ph.D., Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590265
- Sponsor's protocol ID
- NARSAD-9818
- Acronym
- BPII-DEP-LT
- Status last verified
- Aug 2026
- First submitted
- 26 Dec 2007
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bauer MS, Shea N, McBride L, Gavin C. Predictors of service utilization in veterans with bipolar disorder: a prospective study. J Affect Disord. 1997 Jul;44(2-3):159-68. doi: 10.1016/s0165-0327(97)00046-3.
PubMed 9241576Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
PubMed 11132119Golden 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 15800134Kripke DF, mullaney DJ, Gillin JC, et al. Phototherapy of non-seasonal depression. In: Shagass C, Josiassen RC, Bridger WH, et al., eds. Biological Psychiatry. New York: Elsevier Science Publishing Co.; 1986:993-995
Kripke 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 9609674Lam RW, Levitt AJ, Kraus RP, et al. Management issues. In: ed.R.Lam and A.Levitt, ed. Canadian Consensus Guidelines for the Treatment of Seasonal Affective Disorder Clinical & Academic Publishing; 1999:96-114
Magnusson A, Partonen T. The diagnosis, symptomatology, and epidemiology of seasonal affective disorder. CNS Spectr. 2005 Aug;10(8):625-34; quiz 1-14. doi: 10.1017/s1092852900019593.
PubMed 16041294Martiny K, Lunde M, Unden M, Dam H, Bech P. The lack of sustained effect of bright light, after discontinuation, in non-seasonal major depression. Psychol Med. 2006 Sep;36(9):1247-52. doi: 10.1017/S0033291706008105. Epub 2006 Jun 7.
PubMed 16756691Schwitzer J, Neudorfer C, Blecha HG, Fleischhacker WW. Mania as a side effect of phototherapy. Biol Psychiatry. 1990 Sep 15;28(6):532-4. doi: 10.1016/0006-3223(90)90489-o. No abstract available.
PubMed 2132555Stout RL, Wirtz PW, Carbonari JP, Del Boca FK. Ensuring balanced distribution of prognostic factors in treatment outcome research. J Stud Alcohol Suppl. 1994 Dec;12:70-5. doi: 10.15288/jsas.1994.s12.70.
PubMed 7723001Tuunainen 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 15106233Wirz-Justice A, Benedetti F, Berger M, Lam RW, Martiny K, Terman M, Wu JC. Chronotherapeutics (light and wake therapy) in affective disorders. Psychol Med. 2005 Jul;35(7):939-44. doi: 10.1017/s003329170500437x.
PubMed 16045060Yatham LN, Kennedy SH, O'Donovan C, Parikh S, MacQueen G, McIntyre R, Sharma V, Silverstone P, Alda M, Baruch P, Beaulieu S, Daigneault A, Milev R, Young LT, Ravindran A, Schaffer A, Connolly M, Gorman CP; Canadian Network for Mood and Anxiety Treatments. Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder: consensus and controversies. Bipolar Disord. 2005;7 Suppl 3:5-69. doi: 10.1111/j.1399-5618.2005.00219.x.
PubMed 15952957Yatham LN, Kennedy SH, O'Donovan C, Parikh SV, MacQueen G, McIntyre RS, Sharma V, Beaulieu S; Guidelines Group, CANMAT. Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder: update 2007. Bipolar Disord. 2006 Dec;8(6):721-39. doi: 10.1111/j.1399-5618.2006.00432.x.
PubMed 17156158Chaput JP, Despres JP, Bouchard C, Tremblay A. Short sleep duration is associated with reduced leptin levels and increased adiposity: Results from the Quebec family study. Obesity (Silver Spring). 2007 Jan;15(1):253-61. doi: 10.1038/oby.2007.512.
PubMed 17228054
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light-Therapy in the Treatment of the Acute Phase of the Bipolar Type II Depression: Double-Blind, Placebo-Controlled Study to Establish Efficacy and Safety
- ClinicalTrials.gov ID
- NCT00590265
- Acronym / sponsor ID
- BPII-DEP-LT / NARSAD-9818
- Conditions
- Bipolar Type II Disorder, Depression, Bipolar
- Keywords
- bipolar type II disorder, depression, remission, light-therapy, efficacy, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Jan 2008
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 10 Jan 2008 (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.
The purpose of this study is to evaluate the efficacy and safety of light therapy for the treatment of bipolar type II patients relapsing into a depressive phase during autumn or winter.
Detailed description
Bipolar type II depression is a very frequent condition for which we still have a significant lack of acute treatments. There is now consistent evidence that light-therapy treatment produced a significant decrease of depressive symptoms for seasonal and non-seasonal unipolar depression. But there are no long-term studies of light therapy for the treatment of non-seasonal unipolar depression. It is also important to note that many of these studies involved co-therapy with antidepressant drugs or sleep-deprivation, making the interpretation of the results even more difficult.
Therefore, we propose to study the efficacy and safety of light therapy for the treatment of bipolar type II patients relapsing into a depressive phase during the period of September to mid-March. This will be a double-blind randomized placebo-controlled study. Bipolar II out-patients will be recruited from our bipolar disorders program and from our 5 general psychiatry out-patient clinics. We will recruit bipolar type II patients facing a depressive phase and after they give their informed consent and we had verified they meet all inclusion and exclusion criteria, they will be randomized blindly to Bright-light (10 000 lux) vs Dim-light placebo (100 lux) therapies. Both, patient and investigator/rater will be blind to the type of light treatment assigned to the patient. The light therapy will take place during 30 minutes daily in the morning AFTER the usual awakening time of the patient in order to avoid even partial sleep deprivation which would confound the results if we were to observe a greater switch rate into mania or hypomania.
Reasons for study termination can be serious side-effects, development of suicidal ideations or hypomanic/manic symptoms, patient's own decision, or any other of the exclusion criteria being fulfilled during the course of the study.
Depressive and manic/hypomanic symptoms, quality of life, sleep quality and side-effects will be assessed at baseline and during the study. Biological parameters will also be measured along the study. We think that this study will allow us to determine the efficacy and safety of a 5 weeks bright light therapy for Bipolar type II depression and provide open label data as to the long term benefits of this treatment if prolonged over 5 weeks during the "dark" months of the year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Northern Light Technology (SADelite lamp) bright light-therapy |
| 2 | Placebo comparator | Device: Northern Light Technology (SADelite lamp) Dim light-therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bipolar type II disorder, depressive phase meeting DSM-IV criteria as per the SCID interview
- Hamilton Depression Rating Scale 21 items (HAMD-21) ≥ 17 and a Montgomery Asberg rating Scale (MADRS) ≥ 15 for at least 2 weeks and the episode has begun during the month of september or a later month
- Able to give their consent and willingness to participate to the study
Key exclusion criteria (12 listed)
- Other psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, diabetes, cardiac condition, hypertension
- Deficit in vitamin B12 or folate
- Sub-syndromic hypomania symptoms as per a Young Mania Rating Scale (YMRS) score ≥ 4
- History of manic or hypomanic switch when exposed to bright light or during prolonged exposure to the sun during previous depressive phases
- Pregnancy or absence of a contraceptive treatment
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 |
|---|---|---|
| Northern Light Technology (SADelite lamp) bright light-therapyAlso: Northern Light Technology (SADelite lamp) with two 36W bulbs10 000 lux for 30 minutes | Device | 1 |
| Northern Light Technology (SADelite lamp) Dim light-therapyAlso: Northern Light Technology (SADelite lamp) with two 18W bulbs + red filter (Medium Red 27 High Temperature treated, LEE Filters, Y = 3.64%)<100 lux for 30 minutes | Device | 2 |
Primary outcome
the response rate as defined by a 50% improvement of the depressive symptoms score on the MADRS scale
Time frame: 5 and 45 weeks
5 secondary outcomes
the remission rate (MADRS scale ≤ 8 )
Time frame: 5 and 45 weeks
the relapse rate into depression or hypomania
Time frame: 5 and 45 weeks
the sleep quality as per PSQI scale
Time frame: 5 and 45 weeks
the quality of life as per SF-36 and Q-LES-Q SF scales
Time frame: 5 and 45 weeks
the incidence of side-effects as per the UKU scale
Time frame: 5 and 45 weeks
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 27 Aug 2026.
- Background: PubMed 9241576Bauer MS, Shea N, McBride L, Gavin C. Predictors of service utilization in veterans with bipolar disorder: a prospective study. J Affect Disord. 1997 Jul;44(2-3):159-68. doi: 10.1016/s0165-0327(97)00046-3.
- Background: PubMed 11132119Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
- 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.
- BackgroundKripke DF, mullaney DJ, Gillin JC, et al. Phototherapy of non-seasonal depression. In: Shagass C, Josiassen RC, Bridger WH, et al., eds. Biological Psychiatry. New York: Elsevier Science Publishing Co.; 1986:993-995
- 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.
- BackgroundLam RW, Levitt AJ, Kraus RP, et al. Management issues. In: ed.R.Lam and A.Levitt, ed. Canadian Consensus Guidelines for the Treatment of Seasonal Affective Disorder Clinical & Academic Publishing; 1999:96-114
- Background: PubMed 16041294Magnusson A, Partonen T. The diagnosis, symptomatology, and epidemiology of seasonal affective disorder. CNS Spectr. 2005 Aug;10(8):625-34; quiz 1-14. doi: 10.1017/s1092852900019593.
- Background: PubMed 16756691Martiny K, Lunde M, Unden M, Dam H, Bech P. The lack of sustained effect of bright light, after discontinuation, in non-seasonal major depression. Psychol Med. 2006 Sep;36(9):1247-52. doi: 10.1017/S0033291706008105. Epub 2006 Jun 7.
- Background: PubMed 2132555Schwitzer J, Neudorfer C, Blecha HG, Fleischhacker WW. Mania as a side effect of phototherapy. Biol Psychiatry. 1990 Sep 15;28(6):532-4. doi: 10.1016/0006-3223(90)90489-o. No abstract available.
- Background: PubMed 7723001Stout RL, Wirtz PW, Carbonari JP, Del Boca FK. Ensuring balanced distribution of prognostic factors in treatment outcome research. J Stud Alcohol Suppl. 1994 Dec;12:70-5. doi: 10.15288/jsas.1994.s12.70.
- 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 16045060Wirz-Justice A, Benedetti F, Berger M, Lam RW, Martiny K, Terman M, Wu JC. Chronotherapeutics (light and wake therapy) in affective disorders. Psychol Med. 2005 Jul;35(7):939-44. doi: 10.1017/s003329170500437x.
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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.
Serge Beaulieu, Ph.D. principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Northern Light Technology (SADelite lamp) bright light-therapy and Northern Light Technology (SADelite lamp) Dim light-therapy in people with Bipolar Type II Disorder and Depression, Bipolar, run by Douglas Mental Health University Institute 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 3 inclusion and 12 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 27 Aug 2026. 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.
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?
the response rate as defined by a 50% improvement of the depressive symptoms score on the MADRS scale (time frame: 5 and 45 weeks). 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 NCT00590265, which also lists 23 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 27 Aug 2026.