Study identification

EU PAS number

EUPAS1000000893

Study ID

1000000893

Official title and acronym

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

DARWIN EU® study

No

Study countries

Italy

Study description

Single-center, parallel-group, randomized, three-arm controlled trial in adults aged ≥65 years with non-seasonal unipolar Major Depressive Disorder and inadequate response to ongoing SSRI treatment. Participants were followed for 4 weeks of active treatment plus a 1‑month post-treatment follow-up. The protocol was approved by the Milan Area 1 Ethics Committee.
After baseline assessment (ICD-based clinical interview by an expert psychiatrist, collection of clinical history, MMSE cognitive screening, and HAM-D/HAM-A ratings), eligible participants provided written informed consent and were randomized 1:1:1 using a block randomization list held by an independent senior researcher to ensure allocation concealment. A blinded assessor rated outcomes at follow-ups. Participants in the light arms were blinded to light intensity by using identical Philips Energy Up HF 3419 devices differing only in intensity; blinding was not feasible for the SSRI-switch arm.Interventions were: (1) adjunctive bright light therapy 7,500–10,000 lux for 50 minutes each morning for 4 weeks, with SSRI dose maintained when possible; (2) adjunctive placebo light ~20 lux for 50 minutes each morning for 4 weeks with continued SSRI; or (3) discontinuation of the current SSRI and switch to another SSRI within class per guideline-based clinical practice (no light therapy). Primary outcome was response at 4 weeks (T1), defined as ≥50% reduction from baseline in HAM-D and HAM-A. Remission at T1 was defined as HAM-D ≤7 and HAM-A ≤17. Secondary outcomes included symptom change from baseline to T1 and to 1‑month post-treatment follow-up (T2), sustained response/remission at T2, and tolerability/safety (adverse events, discontinuations, withdrawals due to emergencies/hospitalization, and protocol deviations). Planned sample size was 39 (13 per group). Analyses used an intention-to-treat approach, mixed effects models for repeated measures, and binomial m

Study status

Finalised
Research institutions and networks

Institutions

Università degli Studi di Milano

Contact details

Simone Cavallotti

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
No external funding
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable