Seasonal Affective DisorderVAHAVANCT01030276
Bright Light Therapy in Seasonal Affective Disorder (SAD)
A study testing Bright light therapy in people with Seasonal Affective Disorder, run by University of Oulu at 1 site in Finland.
Trial summary
The aim of this study is to investigate the efficacy of bright light therapy in SAD. This is a placebo-controlled, double-blind randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Affective Disorder
- What is being tested?
- Bright light therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2009to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a patient has, according to the DSM-IV-TR, a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)
- HAMD-21 (included in the SIGH-SAD) sum score is ≥ 22
- patient is over 18 years
- 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
- life-time suicide attempt, or any thought of suicide during the last month
- patients has some unstable somatic disorder
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- patient uses some medication on regular basis
- patient uses some herbal psychotropic agencies
- 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 during the current episode
- patient has some eye disease (patient can, however, be myopic or hyperopic)
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Research unit, ODL Terveys Oy, Albertinkatu 18 A
Oulu, FIN-90100 Oulu
Markku J Timonen, Prof, + 358 40 8324883, markku.timonen@oulu.fi
About this study
Official title: Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD
The aim of this study is to investigate the efficacy of bright light therapy in SAD. This is a placebo-controlled, double-blind randomized controlled trial (RCT).
- Conditions
- Seasonal Affective Disorder
- Being tested
- Bright light therapy, Inactive "placebo-light"
- 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.
Bright light therapyOther
Bright light therapy
Inactive "placebo-light"Other
In this arm, patients will not get any bright-light therapy in a double-blind setting
| Study group | Role | What they receive |
|---|---|---|
| Bright light | Experimental | Not described Receives: Other: Bright light therapy |
| Inactive "placebo-light" | Placebo comparator | Not described Receives: Other: Inactive "placebo-light" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission as defined by the SIGH-SAD
Measured: 28 (visit window from 26 to 30 days) days after the inclusion day
Secondary outcomes (1)
Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21
Measured: 28 (visit window from 26 to 30 days) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030276
- Sponsor's protocol ID
- FI (FWA00000190) 11/2008
- Acronym
- VAHAVA
- Status last verified
- Dec 2009
- First submitted
- 10 Dec 2009
- Last updated
- 11 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD
- ClinicalTrials.gov ID
- NCT01030276
- Acronym / sponsor ID
- VAHAVA / FI (FWA00000190) 11/2008
- Conditions
- Seasonal Affective Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 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
- Oct 2009
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 11 Dec 2009 (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 aim of this study is to investigate the efficacy of bright light therapy in SAD. This is a placebo-controlled, double-blind randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright light | Experimental | Other: Bright light therapy |
| Inactive "placebo-light" | Placebo comparator | Other: Inactive "placebo-light" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- a patient has, according to the DSM-IV-TR, a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)
- HAMD-21 (included in the SIGH-SAD) sum score is ≥ 22
- patient is over 18 years
- patient can read and understand the subject information sheet
- patient has signed the informed consent form
Key exclusion criteria (12 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
- life-time suicide attempt, or any thought of suicide during the last month
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 therapyBright light therapy | Other | Bright light |
| Inactive "placebo-light"In this arm, patients will not get any bright-light therapy in a double-blind setting | Other | Inactive "placebo-light" |
Primary outcome
Remission as defined by the SIGH-SAD
Time frame: 28 (visit window from 26 to 30 days) days after the inclusion day
1 secondary outcome
Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21
Time frame: 28 (visit window from 26 to 30 days) days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright light therapy 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 6 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: status not confirmed, as of the sponsor's last update on 11 Dec 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markku J Timonen, Prof (+358 40 8324883, markku.timonen@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission as defined by the SIGH-SAD (time frame: 28 (visit window from 26 to 30 days) days after the inclusion day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2009.