| CTRI Number |
CTRI/2017/01/007751 [Registered on: 31/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
26/12/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of zinc supplementation to antidepressant therapy in patients with unipolar depression |
|
Scientific Title of Study
|
Effect of zinc supplementation on antidepressant therapy and serum zinc level in unipolar depression:A randomized double blind controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr DILEEP KR VERMA |
| Designation |
Resident |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHIATRY |
| Address |
MILLAT COLONY, KANKE, RANCHI CENTRAL INSTITUTE OF PSYCHIATRY,KANKE,RANCHI Ranchi JHARKHAND 834006 India |
| Phone |
07091768783 |
| Fax |
|
| Email |
dr.dileep09@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Basudeb Das |
| Designation |
Professor Of Psychiatry |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHIATRY |
| Address |
CENTRAL INSTITUTE OF PSYCHIATRY,KANKE, RANCHI
Ranchi JHARKHAND 834006 India |
| Phone |
|
| Fax |
|
| Email |
basudeb71@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Basudeb Das |
| Designation |
Professor Of Psychiatry |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHIATRY |
| Address |
CENTRAL INSTITUTE OF PSYCHIATRY,KANKE, RANCHI
Ranchi JHARKHAND 834006 India |
| Phone |
|
| Fax |
|
| Email |
basudeb71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, kanke, Ranchi, 834006 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr DILEEP KUMAR VERMA |
CENTRAL INSTITUTE OF PSYCHIATRY |
KANKE,RANCHI Ranchi JHARKHAND |
07091768783
dr.dileep09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, C.I.P., Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Unipolar depression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Only on antidepressants for 8 weeks |
| Intervention |
zinc |
zinc 20mg OD for 08 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MEAN HAMILTON DEPRESSION SCORE AND MEAN BECK DEPRESSION SCORE |
BASELINE,2 WEEK,4 WEEK & 8 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MEAN SERUM ZINC,ALBUMIN AND C-REACTIVE PROTEIN LEVEL |
BASELINE,2 WEEK,4 WEEK & 8 WEEK |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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). |