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Evaluating the effectiveness of zinc Sulfate in Improvement in Depressive Symptoms in Patients Treated with Selective Serotonin Reuptake inhibitors in Ahvaz Golestan Hospital

Protocol summary

Summary
To evaluate the effectiveness of zinc sulfate in improving depression symptoms in patients treated with selective serotonin Reuptake inhibitors in Ahvaz Golestan Hospital. A clinical demographic questionnaire will be conduct based on information obtained from the patients and their records which include items on age, education, marital status, sex, presence of other diseases such as hypertension, high cholesterol, diabetes, chronic liver failure, and kidney and lung disease. Beck Depression Inventory (BDI) will perform at baseline to measure patients’ depression. Patients with a score of 13 and higher and those who are treated with SSRI drugs for at least 3 months will be enrolled. The patients will be divided randomly into two groups of 30. One group will receive selective serotonin inhibitors (20-60 mg of citalopram or 50-200 mg of sertraline) plus zinc sulfate (25 mg daily), while the other group will receive selective inhibitors (20-60 mg of citalopram or 50-200 mg of sertraline) with placebo (25 mg of malt dextrose daily). Patients will be tested at weeks 2, 4, 6 and 8 to estimate the depression and functional level, using the BDI.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012110411363N1
Registration date: 2017-10-04, 1396/07/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-04, 1396/07/12
Registrant information
Name
Hannaneh Davoodzadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
davoodzadeh.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-04-04, 1395/01/16
Expected recruitment end date
2017-05-23, 1396/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Evaluating the effectiveness of zinc Sulfate in Improvement in Depressive Symptoms in Patients Treated with Selective Serotonin Reuptake inhibitors in Ahvaz Golestan Hospital
Public title
Evaluating the effectiveness of zinc Sulfate in Improvement in Depressive Symptoms in Patients Treated with Selective Serotonin Reuptake inhibitors in Ahvaz Golestan Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18- 80 years; diagnosis of depression based on DSMVITR; Exclusion criteria: neurological complications; chronic physiological diseases; current addiction to opium or alcohol; history of addiction to opium or alcohol in the past 6 months; history of allergy to antidepressants or zine sulfate; use of monoxide inhibitor in the past 8 weeks; history of seizure; history of suicide; liver, renal or cardiac disorder; pregnancy or breast feeding.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2016-11-05, 1395/08/15
Ethics committee reference number
IR.AJUMS.REC.1395.478

Health conditions studied

1

Description of health condition studied
Major Depresion
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms

Primary outcomes

1

Description
Depresion Status
Timepoint
2,4,6,and 8th weeks
Method of measurement
Beck Depression Rating Scale

Secondary outcomes

empty

Intervention groups

1

Description
Taking a Zinc sulfate capsule, 25 mg once a day for 8 weeks (intervention)
Category
Treatment - Drugs

2

Description
Taking a Malt Dexterous placebo once a day for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatric Clinic of Golestan
Full name of responsible person
Masoumeh Nazarinasab
Street address
Psychiatric Clinic of Golestan, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Saaki Naader
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Masoume Nazarinasab
Position
Psychatric Specialist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 3587 4366
Fax
Email
Nazarinasab-m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Masume Nazarinasab
Position
Psychiatric Specialist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 3587 4366
Fax
Email
Nazarinasab-m@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hannaneh Davoodzadeh
Position
Toxicologist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 3587 4366
Fax
Email
davoodzadeh.h@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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