Skip to content

Comparison of antidepressant drug alone versus antidepressant drug plus bright light therapy combination for severe major depressive disorder

Comparison of the efficacy of venlafaxine alone versus venlafaxine plus bright light therapy combination for the treatment of severe major depressive disorder

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001061628
Acronym
None
Enrollment
32
Registered
2014-10-03
Start date
2012-01-01
Completion date
2013-01-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Objective: Phototherapy, i.e., bright light therapy (BLT), is an effective and safe treatment of major depressive disorder (MDD). It exerts rapid mood-elevating activity, similar to antidepressant medications, most likely mediated through both monoaminergic and circadian system melatonergic mechanisms. We assessed the efficiency of BLT as an adjuvant treatment to antidepressant pharmacotherapy in severe MDD patients randomized by Hamilton Depression Rating (HAM-D) scale score either to: (i) 150 mg venlafaxine hydrochloride (VH) daily at 8 a.m. or (ii) 150 mg VH+BLT (30-minute full spectrum light of 10000 lux) daily at 8 a.m. Methods: 50 severe MDD inpatients of the Psychiatry Clinic of Yuzuncu Yil University Training and Education Hospital participated. Mood states were assessed by the HAM-D, Profile of Mood States (POMS), and Beck Depression Inventory (BDI) instruments before and at 1, 2, 4, and 8 weeks of treatment. Results: Based on the HAM-D score as the primary outcome variable, both strategies significantly improved depression and negative mood states already at the 1st treatment week. Therapeutic effects were more remarkable at the 2nd treatment week, with beneficial effects improving until trial conclusion. However, those treated with VH+BLT evidenced significantly lower HAM-D depression and also POMS and BDI negative mood states scores. This more favorable effect of the combination VH+BLT strategy, signified by reduction of the mean score of the HAM-D and other assessment instruments, generally became more remarkable at the 2nd week of the trial and was sustained. At week 4 of the trial, 19 of the 25 (76%) VH+BLT patients vs. just 11 of the 25 (44%) VH patients attained the target goal of treatment, a HAM-D score less than 13 indicative of mild depression, and at week 8, 76% of VH+BLT patients vs. just 64% of the VH ones experienced complete remission of their depression (HAM-D score less than 7). Conclusion: Both VH and VH+BLT treatment strategies significantly reversed the depressive mood of severe MDD patients; however, the latter induced significantly stronger beneficial effects and more rapidly. Future longer-term studies of large sample size, nonetheless, are required to confirm and generalize these results to both severe and mild MDD patients of diverse ethnicities and cultures.

Interventions

Treatment arm 1: Venlafaxine hydrochloride(oral tablet) , a potent serotonin-noradrenaline reuptake inhibitor (SNRI), was started in a dose of 75 mg/day, always in the morning at 8 a.m., for the 1st week of the trial and thereafter, from the 2nd to the 8th week of the trial, provided in a dose of 150 mg/day.150 mg venlafaxine hydrochloride (VH) daily at 8 a.m. Treatment arm 2: Bright Light Treatment plus Venlafaxine hydrochloride. A special light unit (Day Light; Carex Health, Model DL930EU),des

Treatment arm 1: Venlafaxine hydrochloride(oral tablet) , a potent serotonin-noradrenaline reuptake inhibitor (SNRI), was started in a dose of 75 mg/day, always in the morning at 8 a.m., for the 1st week of the trial and thereafter, from the 2nd to the 8th week of the trial, provided in a dose of 150 mg/day.150 mg venlafaxine hydrochloride (VH) daily at 8 a.m. Treatment arm 2: Bright Light Treatment plus Venlafaxine hydrochloride. A special light unit (Day Light; Carex Health, Model DL930EU),designed and marketed for medical use, was positioned at eye level 60 cm from the patient to deliver full spectrum light of 10000 lux BLT for 30 minutes daily at 8 a.m., immediately following the same dose in treatment arm 1, Venlafaxine hydrochloride ingestion 75mg/day for week 1 and 150mg/day for weeks 2-8. Patients were instructed not to gaze directly into the light, and they were supervised to ensure their eyes remained open throughout each Bright light treatment session. 150 mg Venlafaxine+Bright light treatment (30-minute full spectrum light of 10000 lux) daily at 8 a.m. We used drug tablet return to monitor adherence.

Sponsors

Yuzuncu Yil University, Scientific Research Projects Office
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

First-time diagnosis of severe Major Depressive Disorder (DSM-IV-TR; Structured Clinical Interview for DSM-IV Axis I disorders, SCID-I) Age between 18 and 65. Being voluntary.

Exclusion criteria

Current or history of bipolar disorders, history of drug abuse or addiction

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026