Seasonal Affective DisorderNCT01293409
Bright Light Therapy in Seasonal Affective Disorder (SAD)
A study testing Transcranial Brain-Targeted Bright Light Treatment in people with Seasonal Affective Disorder, run by University of Oulu at 1 site in Finland.
Trial summary
Bright light therapy (BLT) is widely accepted as first-line treatment of seasonal affective disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the other hand, in mammals, light penetrates the skull bone and reaches the brain, and extra ocular transcranial phototransduction has… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Affective Disorder
- What is being tested?
- Transcranial Brain-Targeted Bright Light Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2010to Mar 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision [DSM-IV-TR]) a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)
- The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20
- The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20
- The 21-item Hamilton Depression Rating Scale score ≥ 10
- The 8-item atypical symptom score ≥ 5
- patient is over 18 years
Show all 9Show fewer
- patient can read and understand the subject information sheet
- patient has signed the informed consent form
- patient is not pregnant
Who cannot join
- patient has a lifetime psychotic disorder
- patient has a DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI
- patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study treatment according to the investigator
- patient has alcohol or some other substance use dependence or misuse
- patients has some unstable somatic disorder
- patient uses some psychotropic agencies
Show all 9Show fewer
- patient is, in the opinion of the investigator, unsuitable for any reason
- patient is a member of the site personnel or their immediate families
- patient has had bright light therapy via ear canals during the current episode
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Brain-Targeted Bright Light Treatment Via Ear Canals in Seasonal Affective Disorder (SAD) - a Randomized Placebo Controlled Dose Finding Study
Bright light therapy (BLT) is widely accepted as first-line treatment of seasonal affective disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the other hand, in mammals, light penetrates the skull bone and reaches the brain, and extra ocular transcranial phototransduction has physiological influences such as changed reproductive cycles and increased brain serotonin levels. Therefore, the investigators run a randomized, placebo controlled, double blind, dose finding study on the putative effect of transcranial bright light in the treatment of SAD.
- Conditions
- Seasonal Affective Disorder
- Being tested
- Transcranial Brain-Targeted Bright Light Treatment
- Medical subject headings
- Seasonal Affective Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Brain-Targeted Bright Light TreatmentOther
Also called VALKEE
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The amount of photic energy of light is considered to be non-therapeutical Receives: Other: Transcranial Brain-Targeted Bright Light Treatment |
| Intermediate dose | Experimental | The amount of photic energy of bright light is considered to be "intermediate" Receives: Other: Transcranial Brain-Targeted Bright Light Treatment |
| High dose bright light | Experimental | The amount of photic energy of bright light is considered to be fully therapeutic Receives: Other: Transcranial Brain-Targeted Bright Light Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
Remission, i.e., the 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
Measured: At the end of the four-week study period
Secondary outcomes (5)
≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD
Measured: At the end of the four-week study period
≥ 50 % decrease of the severity of symptoms as assessed by the 14-item Hamilton Anxiety Rating Scale total score
Measured: At the end of the four-week study period
≥ 50 % decrease of the severity of symptoms as assessed by the 21-item Beck depression Inventory (BDI-21) total score
Measured: At the end of the four-week study period
≥ 50 % decrease of the severity of symptoms as assessed by 21-item Hamilton Depression Rating Scale total score
Measured: At the end of the four-week study period
A number of participants with bright light therapy related (according to physician decision) adverse events as a measure of safety and tolerability
Measured: During the four week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Affective 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital, ODL Terveys Oy, Valkee Oy, University of Eastern Finland
- Investigators
- Pirkko Räsänen, M.D., Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293409
- Sponsor's protocol ID
- FI (FWA00000190) 11/2008b
- Status last verified
- May 2011
- First submitted
- 21 Jan 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jurvelin H, Takala T, Nissila J, Timonen M, Ruger M, Jokelainen J, Rasanen P. Transcranial bright light treatment via the ear canals in seasonal affective disorder: a randomized, double-blind dose-response study. BMC Psychiatry. 2014 Oct 21;14:288. doi: 10.1186/s12888-014-0288-6.
PubMed 25330838
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Brain-Targeted Bright Light Treatment Via Ear Canals in Seasonal Affective Disorder (SAD) - a Randomized Placebo Controlled Dose Finding Study
- ClinicalTrials.gov ID
- NCT01293409
- Acronym / sponsor ID
- FI (FWA00000190) 11/2008b
- Conditions
- Seasonal Affective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital, ODL Terveys Oy, Valkee Oy, University of Eastern Finland
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Feb 2011 (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 (BLT) is widely accepted as first-line treatment of seasonal affective disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the other hand, in mammals, light penetrates the skull bone and reaches the brain, and extra ocular transcranial phototransduction has physiological influences such as changed reproductive cycles and increased brain serotonin levels. Therefore, the investigators run a randomized, placebo controlled, double blind, dose finding study on the putative effect of transcranial bright light in the treatment of SAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Transcranial Brain-Targeted Bright Light TreatmentThe amount of photic energy of light is considered to be non-therapeutical |
| Intermediate dose | Experimental | Other: Transcranial Brain-Targeted Bright Light TreatmentThe amount of photic energy of bright light is considered to be "intermediate" |
| High dose bright light | Experimental | Other: Transcranial Brain-Targeted Bright Light TreatmentThe amount of photic energy of bright light is considered to be fully therapeutic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- a patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision [DSM-IV-TR]) a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)
- The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20
- The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20
- The 21-item Hamilton Depression Rating Scale score ≥ 10
- The 8-item atypical symptom score ≥ 5
Key exclusion criteria (9 listed)
- patient has a lifetime psychotic disorder
- patient has a DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI
- patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study treatment according to the investigator
- patient has alcohol or some other substance use dependence or misuse
- patients has some unstable somatic disorder
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 |
|---|---|---|
| Transcranial Brain-Targeted Bright Light TreatmentAlso: VALKEETranscranial Brain-Targeted Bright Light Treatment via Ear Canals | Other | High dose bright light, Intermediate dose, Placebo |
Primary outcome
The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
Time frame: At the end of the four-week study period
Remission, i.e., the 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
5 secondary outcomes
≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD
Time frame: At the end of the four-week study period
≥ 50 % decrease of the severity of symptoms as assessed by the 14-item Hamilton Anxiety Rating Scale total score
Time frame: At the end of the four-week study period
≥ 50 % decrease of the severity of symptoms as assessed by the 21-item Beck depression Inventory (BDI-21) total score
Time frame: At the end of the four-week study period
≥ 50 % decrease of the severity of symptoms as assessed by 21-item Hamilton Depression Rating Scale total score
Time frame: At the end of the four-week study period
A number of participants with bright light therapy related (according to physician decision) adverse events as a measure of safety and tolerability
Time frame: During the four week study 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 1 Jun 2011.
- Derived from this study: PubMed 25330838Jurvelin H, Takala T, Nissila J, Timonen M, Ruger M, Jokelainen J, Rasanen P. Transcranial bright light treatment via the ear canals in seasonal affective disorder: a randomized, double-blind dose-response study. BMC Psychiatry. 2014 Oct 21;14:288. doi: 10.1186/s12888-014-0288-6.
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Seasonal Affective Disorder (SAD)
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.
Pirkko Räsänen, M.D., Ph.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Brain-Targeted Bright Light Treatment in people with Seasonal Affective Disorder, run by University of Oulu at 1 site in Finland.
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 9 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 1 Jun 2011. 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 Finland. 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 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8 (time frame: At the end of the four-week study period). 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 NCT01293409, which also lists 1 linked publication.
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 1 Jun 2011.