Comparative Efficacy of Adjunctive Bright Light Therapy Versus Placebo Light and SSRI Switch in Older Adults With Inadequate SSRI Response: A Single-Center Randomized Controlled Trial

Study type

• Study topic:
  Other
• Study topic, other:
  Medical device vs medication
• Study type:
  Clinical trial
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Clinical trials

• Clinical trial regulatory scope:
  Clinical trial not part of marketing authorisation application or subject to marketing authorisation approval
• Clinical trial phase:
  Therapeutic use (Phase IV)
• Clinical trial randomisation:
  Randomised clinical trial
• Clinical trial types:
  Pragmatic clinical trial

Study drug and medical condition

• Medical condition to be studied:
  Major depression

Population studied

• Short description of the study population:
  The study population consisted of community-dwelling men and women aged 65 years or older with a diagnosis of non-seasonal unipolar Major Depressive Disorder and an inadequate clinical response to ongoing SSRI treatment at guideline-concordant doses. Participants were recruited from a tertiary outpatient service specializing in late-life depression and were required to have sufficient cognitive functioning to provide informed consent and adhere to study procedures. Individuals with other psychiatric disorders, significant cognitive impairment, photosensitivity or ocular conditions contraindicating light exposure, or active substance abuse were excluded.
• Age groups:
  • Elderly (≥ 65 years)

    • Adults (65 to < 75 years)
    • Adults (75 to < 85 years)
    • Adults (85 years and over)
• Special population of interest:
  Frail population
• Estimated number of subjects:
  39

Study design details

• Study design:
  Single-center, randomized, three-arm controlled trial in adults ≥65 years with SSRI-resistant non-seasonal MDD, comparing adjunctive bright light therapy, placebo light, or SSRI switch over 4 weeks with 1-month follow-up.
• Main study objective:
  To evaluate the efficacy and tolerability of adjunctive bright light therapy compared with placebo light exposure and with switching to a different SSRI in elderly patients with non-seasonal major depressive disorder and inadequate response to ongoing SSRI treatment.
• Setting:
  The study was conducted at the outpatient service of San Paolo University Hospital, a tertiary care center specializing in the treatment of depressive disorders in elderly patients.
• Interventions:
  Adjunctive bright light therapy (7,500–10,000 lux, 50 minutes each morning for 4 weeks) added to ongoing SSRI treatment
• Comparators:
  Adjunctive placebo light exposure (20 lux) with the same schedule and device; or discontinuation of the current SSRI and switch to a different SSRI according to clinical guidelines, without light therapy.
• Outcomes:
  The primary outcome was treatment response at 4 weeks, defined as a ≥50% reduction in HAM-D and HAM-A scores. Secondary outcomes included remission rates, changes in symptom severity from baseline to 4 weeks and 1-month follow-up, sustained response/remission, and tolerability and safety.
• Data analysis plan:
  Analyses followed an intention-to-treat approach. Longitudinal changes in HAM-D and HAM-A were examined using mixed-effects log-linear regression models. Treatment response and remission were analyzed with binomial generalized linear models, with Tukey correction for multiple comparisons and significance set at p < 0.05.
• Summary results:
  Depressive and anxiety symptoms decreased significantly over time in all three arms. At 4 weeks, the SSRI-switch arm showed greater improvement in mean HAM-D scores than placebo, whereas BLT did not differ significantly from either comparator, and no significant between-group differences were observed in response or remission rates.