The effectiveness of endocrine disorders therapy in depression improvement of HIV infected men referring to counseling center at Imam Khomeini hospital in 92
1) Objective: Evaluation of effectiveness of endocrine disorders therapy in depression improvement of HIV infected men.
2) Design: This study is Interventional on HIV positive patients in whom Beck score is more than 21 with hormonal treatment.
3) Setting and conduct: 104 HIV infected men in counseling center of Imam Khomeini hospital in whom Beck score is more than 21 will be selected and endocrine tests will be done for them.The patients with endocrine disorders confirmed by lab tests, will be treated with hormonal medications and reevaluation of depression with beck questionnaire will be done in the end of treatment.
4) Major eligibility criteria:
Inclusion criteria: HIV+ confirmed by Western Blot; Patient on ART treatment; beck questionnaire with score>21
Exclusion criteria: Consumption of antidepressant drugs; Confirmed endocrine disorder ; Any sign of infectious disease such as fever; Opportunistic infections; addiction; Major depression with suicidal attempt or emotional events in last month.
5) Intervention: Hormonal medications in depressed patients.
6) main outcome measures variables: Depression with beck questionnaire
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071914054N1
Registration date:2013-12-25, 1392/10/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-25, 1392/10/04
Registrant information
Name
Ladan Abbasian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1598
Email address
la-abbasian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-12-01, 1392/09/10
Expected recruitment end date
2014-12-01, 1393/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of endocrine disorders therapy in depression improvement of HIV infected men referring to counseling center at Imam Khomeini hospital in 92
Public title
The effectiveness of endocrine disorders therapy in depression improvement of HIV infected men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: HIV+ confirmed by Western Blot; Patient on ART treatment; beck questionnaire with score>21
Exclusion criteria: Consumption of antidepressant drugs; Confirmed endocrine disorder ; Any sign of infectious disease such as fever; Opportunistic infections; addiction; Major depression with suicidal attempt or emotional events in last month.
Age
From 18 years old to 80 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Ghods St
City
Tehran
Postal code
Approval date
2013-07-15, 1392/04/24
Ethics committee reference number
92-01-30-21556-89225
Health conditions studied
1
Description of health condition studied
HIV infected people
ICD-10 code
B24
ICD-10 code description
Unspecified human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Depression
Timepoint
Detection of depression before and after intervention
For treatment if we will have hypogonadism testosterone 250 unit monthly will given,in cases of hypothyroidism levothyroxine 100 macro gram daily and in cases of hyperthyroidism methimazole 15 mg daily for 3 weeks and then 10 mg daily will prescribed.For hypocortisolism as a 20 mg hydrocortisone will given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
HIV Clinic
Full name of responsible person
Ladan Abbasian
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Hajar Moamaii
Street address
Keshavarz Blvd, Qods street
City
Tehran
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 Tehran 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
Iranian research center for HIV/ AIDS
Full name of responsible person
Fereshte Ghiasvand
Position
Infectiouse Diseases Resident
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 3379 7255
Fax
Email
ghiasvand_62@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Research Center for HIV/ AIDS
Full name of responsible person
Ladan Abbasian
Position
MD, MPH, Infectious Disease Specialist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6658 1598
Fax
Email
la.abbasian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian Research Center for HIV/AIDS
Full name of responsible person
Fereshte Ghiasvand
Position
Infectious Diseases Resident
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 3379 7255
Fax
Email
ghiasvand_62@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)