Bipolar DisorderPhase 3NCT00852592
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
A Phase 3 study testing 7000lux broad-spectrum light and 50lux dim red light in people with Bipolar Disorder and Major Depressive Episode, run by Northwestern University at 2 sites in United States.
Trial summary
The purpose of this study is to understand the efficacy of light therapy for bipolar depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Major Depressive Episode
- What is being tested?
- 7000lux broad-spectrum light and 50lux dim red light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Feb 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ages 18-65 years
- DSM-IV Criteria BD I or II depressive episode,
- SIGH-ADS >20; duration >2 weeks.
- Stable dose antidepressant drug >8 weeks with concurrent antimanic drug
- Controlled thyroid disease
- Subjects with preexisting eye diseases will be included.
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- Able to provide informed consent
- Stable minimum dose antimanic drug >4weeks: lithium 0.5 mEq/L, divalproex Na 50 mcg/mL, olanzapine 5mg daily, carbamazepine 4mg/L; lamotrigine 100mg daily, risperidone 2mg daily, quetiapine 400 mg daily, ziprasidone 10 mg bid, and aripiprazole 5 mg qd.
- Stable unchanged psychotherapy for >16weeks
Who cannot join
- The following eye diseases: retinal disease, cataract surgery and lens removal, macular degeneration,
- Taking photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
- Acute psychosis (DSM-IV Criteria)
- Rapid cycling in the past 1 year
- Obsessive compulsive disorder
- Alcohol or substance abuse or dependence in the past 6 months.
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- MRS>5
- Recent history of a suicide attempt (3 months) or active suicidal Ideation (SIGHADS item H11 >2)
- Beta-adrenergic blockers, exogenous melatonin, chronic NSAIDS
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
The purpose of this study is to understand the efficacy of light therapy for bipolar depression.
Read the detailed description
Bipolar Disorders (BD) are associated with chronic depression, disability, and increased suicide risk. Building on earlier findings, we conducted a 6-week randomized, double-blind, placebo-controlled trial to investigate the efficacy of midday light therapy for bipolar depression. The aims were to examine the change in depression levels and the proportion of patients who responded and remitted. We assessed predictors of response with measures of side effects, sleep quality, suicidality, and psychosocial functioning. We included depressed adults with BD-Type I or II confirmed on the SCID interview and taking stable-dosed antimanic medication. We excluded patients with psychosis, rapid cycling, obsessive compulsive disorder, alcohol or substance use disorders, hypomania or mania, and severe suicidality. Patients were randomized to 7000 lux broad spectrum light therapy OR 50 lux dim red light for 45-60 minutes daily. Weekly, the blinded-clinician assessed symptoms with the Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement (SIGH-ADS) and global functioning.
- Conditions
- Bipolar Disorder, Major Depressive Episode
- Being tested
- 7000lux broad-spectrum light, 50lux dim red light
- Keywords
- Bipolar Disorder Depression Midday Light Therapy, Bipolar Disorder Type I or II
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7000lux broad-spectrum lightDevice
dosage - 15-60minutes NOON-2PM daily
50lux dim red lightDevice
dosage: 15-60minutes NOON-2PM daily
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | 7000lux broad-spectrum light Receives: Device: 7000lux broad-spectrum light |
| Inactive Comparator | Placebo comparator | 50lux dim red light Receives: Device: 50lux dim red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIGH-ADS Depression Score
The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.
Measured: 6 weeks
Secondary outcomes (1)
Global Assessment of Functioning (GAF)
The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Dorothy Sit, Northwestern University
- Investigators
- Dorothy K Sit, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852592
- Sponsor's protocol ID
- PRO09020546
- Status last verified
- Sep 2016
- First submitted
- 25 Feb 2009
- Last updated
- 7 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: We can share data if approached by other investigators
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00852592
- Acronym / sponsor ID
- PRO09020546
- Conditions
- Bipolar Disorder, Major Depressive Episode
- Keywords
- Bipolar Disorder Depression Midday Light Therapy, Bipolar Disorder Type I or II
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- May 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Posted 7 Nov 2016
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 understand the efficacy of light therapy for bipolar depression.
Detailed description
Bipolar Disorders (BD) are associated with chronic depression, disability, and increased suicide risk. Building on earlier findings, we conducted a 6-week randomized, double-blind, placebo-controlled trial to investigate the efficacy of midday light therapy for bipolar depression. The aims were to examine the change in depression levels and the proportion of patients who responded and remitted. We assessed predictors of response with measures of side effects, sleep quality, suicidality, and psychosocial functioning. We included depressed adults with BD-Type I or II confirmed on the SCID interview and taking stable-dosed antimanic medication. We excluded patients with psychosis, rapid cycling, obsessive compulsive disorder, alcohol or substance use disorders, hypomania or mania, and severe suicidality. Patients were randomized to 7000 lux broad spectrum light therapy OR 50 lux dim red light for 45-60 minutes daily. Weekly, the blinded-clinician assessed symptoms with the Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement (SIGH-ADS) and global functioning.
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 |
|---|---|---|
| Active Comparator | Active comparator | Device: 7000lux broad-spectrum light7000lux broad-spectrum light |
| Inactive Comparator | Placebo comparator | Device: 50lux dim red light50lux dim red light |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages 18-65 years
- DSM-IV Criteria BD I or II depressive episode,
- SIGH-ADS >20; duration >2 weeks.
- Stable dose antidepressant drug >8 weeks with concurrent antimanic drug
- Controlled thyroid disease
Key exclusion criteria (9 listed)
- The following eye diseases: retinal disease, cataract surgery and lens removal, macular degeneration,
- Taking photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
- Acute psychosis (DSM-IV Criteria)
- Rapid cycling in the past 1 year
- Obsessive compulsive 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 |
|---|---|---|
| 7000lux broad-spectrum lightdosage - 15-60minutes NOON-2PM daily | Device | Active Comparator |
| 50lux dim red lightdosage: 15-60minutes NOON-2PM daily | Device | Inactive Comparator |
Primary outcome
SIGH-ADS Depression Score
Time frame: 6 weeks
The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.
1 secondary outcome
Global Assessment of Functioning (GAF)
Time frame: 6-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28969438Sit 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.
- Individual participant dataSharing planned: Undecided. We can share data if approached by other investigators
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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.
Dorothy K Sit, M.D. principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 7000lux broad-spectrum light and 50lux dim red light in people with Bipolar Disorder and Major Depressive Episode, run by Northwestern University at 2 sites in United States.
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 7 Nov 2016. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
SIGH-ADS Depression Score (time frame: 6 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 NCT00852592, 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 7 Nov 2016.