Effect of zinc supplementation to antidepressant therapy in patients with unipolar depression

Completed

• Conditions: Unipolar depression

• Registration Number: CTRI/2017/01/007751

Brief Summary

The study was a hospital based double blind randomised controlled trial conducted at Central Institute of Psychiatry (CIP), Ranchi between September 2013 and January 2015. Aimed to assess the efficacy of zinc supplementation as an intervention for depressive symptoms, difference in zinc levels before and after treatment and to assess correlation of zinc level with albumin and C-RP. Subjects were recruited into two groups by simple random sampling technique using computer generated randomization. Sample size was consisted of 60 drug naïve (or drug free for minimum 2wks) cases of depressive episode or recurrent depressive disorder according to ICD-10 and fulfilling inclusion and exclusion criteria’s and all subjects gave informed consent. Detailed socio-demographic and clinical data was collected for every subjects. Baseline weight, basal metabolic rate (BMI-Kg/m2), blood pressure recorded after that clinical scales (HAM-D, BDI, BPRS, BSSI, SES, HAM-A, CGI, UKU) were applied in our study on patients to assess baseline status. Blood samples was drawn to assess baseline complete hemogram, LFT, RFT, TFT, FBS, lipid profile along with serum zinc, C–RP and albumin. For patients selected for zinc supplementation, 20mg of elemental zinc daily was given along with antidepressants and other group was without zinc supplementation, rater was kept blind. Blood tests and clinical assessment was repeated after 2, 4 & 8 wks. Serum zinc measurement was done by chemistry analysis (semi-automated method) (normal reference range 60-120 µg/dl). Serum albumin by Bromo Cresol Green Method (normal reference range 3.5-5.5 mg/dl). C-reactive protein by Latex agglutination method (semi quantitative test) (normal<5mg/L).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-09
• Last Update Posted: 2016-12-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Diagnosed cases of depressive episode and recurrent depressive disorder according to ICD-10 DCR (WHO, 1993).
• 2.Status of patient should be drug naïve or drug free for minimum 2 weeks.
• 3.Patients giving written informed consent.

Exclusion Criteria

• 1.Presence of comorbid psychiatric disorder.
• 2.Individuals with history of substance use meeting dependence criteria, other than nicotine and caffeine.
• 3.Co-morbid medical illness known to affect zinc level including acute or chronic inflammatory disorder and neurological disorder.
• 4.ECT during index episode.
• 5.Patient on multivitamin supplementation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MEAN HAMILTON DEPRESSION SCORE AND MEAN BECK DEPRESSION SCORE	BASELINE,2 WEEK,4 WEEK & 8 WEEK

Secondary Outcome Measures

Name	Time	Method
MEAN SERUM ZINC,ALBUMIN AND C-REACTIVE PROTEIN LEVEL	BASELINE,2 WEEK,4 WEEK & 8 WEEK

Trial Locations

Locations (1)

CENTRAL INSTITUTE OF PSYCHIATRY; 🇮🇳 Ranchi, JHARKHAND, India

CENTRAL INSTITUTE OF PSYCHIATRY

🇮🇳Ranchi, JHARKHAND, India

Dr DILEEP KUMAR VERMA

Principal investigator

07091768783

dr.dileep09@gmail.com