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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001061628
• Date of registration: 03/10/2014
• Prospective Registration: No
• Primary sponsor: Yuzuncu Yil University, Scientific Research Projects Office
• Public title: Comparison of antidepressant drug alone versus antidepressant drug plus bright light therapy combination for severe major depressive disorder
• Scientific title: Comparison of the efficacy of venlafaxine alone versus venlafaxine plus bright light therapy combination for the treatment of severe major depressive disorder
• Date of first enrolment: 01/01/2012
• Target sample size: 32
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001061628.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;
• Phase: Not Applicable

Countries of recruitment

Turkey

Contacts

• Name: Dr Pinar Guzel Ozdemir

• Name: Dr Ekrem Yilmaz

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Major Depression;
Major Depression

Mental Health - Depression

Intervention(s)

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.

Primary Outcome(s)

Depression level as assessed using the Hamilton Depression Rating (HAM-D) score[at baseline and at 1, 2,4 and 8 weeks after intervention commencement]

Secondary Outcome(s)

Profile of Mood States (POMS) subscale scores[Timepoint: at baseline and at 2 and 8 weeks after intervention commencement]

Beck Depression Inventory (BDI) score

[at baseline and at 2 and 8 weeks after intervention commencement]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Yuzuncu Yil University, Scientific Research Projects Office

Ethics review

Status: Approved
Approval date:
Contact:

Clinical Ethics and Research Committee of the Yuzuncu Yil University, Faculty of Medicine.