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Trial registered on ANZCTR


Registration number
ACTRN12614001061628
Ethics application status
Approved
Date submitted
29/08/2014
Date registered
3/10/2014
Date last updated
3/10/2014
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 285263 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 292909 0
Condition category
Condition code
Mental Health 293198 293198 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 290142 0
Treatment: Devices
Intervention code [2] 290196 0
Treatment: Drugs
Comparator / control treatment
Treatment arm 1:Venlafaxine was started 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.
Control group
Active

Outcomes
Primary outcome [1] 293068 0
Depression level as assessed using the Hamilton Depression Rating (HAM-D) score
Timepoint [1] 293068 0
at baseline and at 1, 2,4 and 8 weeks after intervention commencement
Secondary outcome [1] 310285 0
Beck Depression Inventory (BDI) score

Timepoint [1] 310285 0
at baseline and at 2 and 8 weeks after intervention commencement
Secondary outcome [2] 310352 0
Profile of Mood States (POMS) subscale scores
Timepoint [2] 310352 0
Timepoint: at baseline and at 2 and 8 weeks after intervention commencement

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current or history of bipolar disorders, history of drug abuse or addiction


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Descriptive sample statistics will be derived for the demographic variables, and sample characteristics were compared between the two treatment groups using F and chi-square test statistics. Repeated measure analysis of variance (rANOVA) models were run to evaluate change on scale and subscale instrument scores obtained over the 8-week course of therapy. In addition, mean scale scores of these assessment instruments obtained at each of five time points, i.e., baseline and after 1, 2, 4, and 8 weeks of Venlafaxine or Venlafaxine and bright light therapy, were compared by one-way ANOVA to assess potential differences in the speed of therapeutic response. The threshold for statistical significance was always p<.05. The number of participants was determined by statistical assumptions supporting sample size calculations, e.g. power. Considering prior studies, we calculated at least a minimum number of 16 observations were needed in each group to obtain a power of 0.80 at a p<.05 significance level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6327 0
Turkey
State/province [1] 6327 0
Van

Funding & Sponsors
Funding source category [1] 289883 0
University
Name [1] 289883 0
Yuzuncu Yil University, Scientific Research Projects Office
Address [1] 289883 0
Yuzuncu Yil University, Campus Street 1.
Postcode: 65000,Van, Turkey
Country [1] 289883 0
Turkey
Primary sponsor type
University
Name
Yuzuncu Yil University, Scientific Research Projects Office
Address
Yuzuncu Yil University, Campus Street 1.
Postcode: 65000,Van, Turkey
Country
Turkey
Secondary sponsor category [1] 288563 0
None
Name [1] 288563 0
Address [1] 288563 0
Country [1] 288563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291606 0
Clinical Ethics and Research Committee of the Yuzuncu Yil University, Faculty of Medicine.
Ethics committee address [1] 291606 0
Yuzuncu Yil University, Faculty of Medicine, Dursun Odabas Training and Research Hospital
Postcode:65300
Van, Turkey
Ethics committee country [1] 291606 0
Turkey
Date submitted for ethics approval [1] 291606 0
Approval date [1] 291606 0
01/01/2012
Ethics approval number [1] 291606 0

Summary
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.
Trial website
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 51122 0
Dr Pinar Guzel Ozdemir
Address 51122 0
Psychiatry Clinic of Yuzuncu Yil University Training and Education Hospital, Campus Street 1.
Postcode:65300
Van Turkey
Country 51122 0
Turkey
Phone 51122 0
+90 432 216 75 19
Fax 51122 0
Email 51122 0
pguzelozdemir@yahoo.com
Contact person for public queries
Name 51123 0
Dr Ekrem Yilmaz
Address 51123 0
Psychiatry Clinic of Yuzuncu Yil University Training and
Education Hospital, Campus Street 1.
Postcode:65300
Van Turkey
Country 51123 0
Turkey
Phone 51123 0
+90 542 5270442
Fax 51123 0
Email 51123 0
ekrem.yilmaz.84@hotmail.com
Contact person for scientific queries
Name 51124 0
Dr Pinar Guzel Ozdemir
Address 51124 0
Psychiatry Clinic of Yuzuncu Yil University Training and
Education Hospital, Campus Street 1.
Postcode:65300
Van Turkey
Country 51124 0
Turkey
Phone 51124 0
+90 432 216 75 19
Fax 51124 0
Email 51124 0
pguzelozdemir@yahoo.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary