Methods |
Allocation: randomized, 'randomly assigned to three treatment modalities'.
Blinding: double blind, 'raters blind to treatment modality'.
Duration: 6 weeks (light treatment 4 weeks). |
Participants |
Diagnosis: Major depressive disorder. First episode (N = 12), recurrent (N = 23), bipolar (N=6), dysthymia (N = 1). DSM‐III‐R.
Inclusion criteria: HDRS (17‐item) 18 or more.
Exclusion criteria: medical illness, hormone replacement therapy.
N = 42.
Age: mean 52.1 years.
Sex: F 20, M 22.
History: duration of illness mean 7.7 years.
Setting: inpatients. |
Interventions |
1. Bright light (5000 lux 5.30‐7.30 PM for 2 hours) + trimipramine. N = 14.
2. LPSD + trimipramine. N = 14.
3. Trimipramine. N = 14.
Device: light box. |
Outcomes |
Clinical improvement (50% reduction HDRS).
Mental state (HDRS, MADRS, D‐S, VAS).
Adverse effects (FSUCL).
Physiological monitoring (ECG, lab, neuroendocrinological measurements). |
Notes |
Light adjunct to pharmacotherapy.
Only interventions 1. and 3. compared. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |