Bipolar Disorder, Major Depressive Episode
Conditions
Keywords
Bipolar Disorder Depression Midday Light Therapy, Bipolar Disorder Type I or II
Brief summary
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.
Interventions
DEVICE7000lux broad-spectrum light
dosage - 15-60minutes NOON-2PM daily
DEVICE50lux dim red light
dosage: 15-60minutes NOON-2PM daily
Sponsors
University of Pittsburgh
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SIGH-ADS Depression Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of Functioning (GAF) | 6-weeks | The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator active light unit
active light therapy unit: dosage - 15-60minutes NOON-2PM daily | 23 |
| Inactive Comparator inactive light unit
Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Active Comparator | Inactive Comparator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 23 Participants | 46 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 12 | 45 years STANDARD_DEVIATION 15 | 44 years STANDARD_DEVIATION 13 |
| Global Assessment of Functioning (GAF) | 57.4 units on a scale STANDARD_DEVIATION 5.61 | 53.5 units on a scale STANDARD_DEVIATION 5.32 | 55.4 units on a scale STANDARD_DEVIATION 5.76 |
| Region of Enrollment United States | 23 participants | 23 participants | 46 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
| SIGH-ADS depression score | 26.1 units on a scale STANDARD_DEVIATION 5.2 | 30.1 units on a scale STANDARD_DEVIATION 6.1 | 28.1 units on a scale STANDARD_DEVIATION 5.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Light Unit | SIGH-ADS Depression Score | 10.3 units on a scale | Standard Deviation 8.18 |
| Inactive Light Unit | SIGH-ADS Depression Score | 17.3 units on a scale | Standard Deviation 9.53 |
p-value: =0.005ANOVA
Secondary
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.
Time frame: 6-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Light Unit | Global Assessment of Functioning (GAF) | 73.9 units on a scale | Standard Deviation 9.77 |
| Inactive Light Unit | Global Assessment of Functioning (GAF) | 65.2 units on a scale | Standard Deviation 9.83 |
p-value: =0.004ANOVA