ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00852592PRO09020546NCT00852592Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled TrialEfficacy of Light Therapy for Bipolar Depression: A Randomized Controlled TrialNorthwestern UniversityOtherUniversity of PittsburghOtherYes
The purpose of this study is to understand the efficacy of light therapy for bipolar
depression.
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.
CompletedMay 2009February 2015December 2014Phase 3InterventionalNoRandomizedParallel AssignmentTreatmentTriple (Participant, Investigator, Outcomes Assessor)SIGH-ADS Depression Score6 weeksThe 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.Global Assessment of Functioning (GAF)6-weeksThe GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.246Bipolar DisorderMajor Depressive EpisodeActive ComparatorActive Comparator7000lux broad-spectrum lightInactive ComparatorPlacebo Comparator50lux dim red lightDevice7000lux broad-spectrum lightdosage - 15-60minutes NOON-2PM dailyActive ComparatorDevice50lux dim red lightdosage: 15-60minutes NOON-2PM dailyInactive Comparator
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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.
- 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
All18 Years65 YearsNoDorothy K Sit, M.D.Principal InvestigatorUniversity of PittsburghUniversity of Pittsburgh, Western Psychiatric Institute and ClinicPittsburghPennsylvania15213United StatesUniversity of PittsburghPittsburghPennsylvania15213United StatesUnited StatesSeptember 2016February 25, 2009February 26, 2009February 27, 2009February 19, 2016September 20, 2016November 6, 2016September 20, 2016September 20, 2016November 6, 2016Principal InvestigatorNorthwestern UniversityDorothy SitAssociate Professor of Psychiatry and Behavioral SciencesBipolar Disorder Depression Midday Light TherapyBipolar Disorder Type I or IIDepressionBipolar DisorderUndecidedWe can share data if approached by other investigators