The aim of this placebo controlled double blind randomized clinical trial will be to assess the efficacy of cyproheptadine for prevention of neuropsychiatric effects of EFV. Inclusion criteria are patients with HIV-1 infection older than 18 years who are scheduled to receive an efavirenz-containing treatment. The main exclusion criteria are pervious treatment with antiretroviral drugs including efavirenz, having major psychiatric disorders like depression at the beginning of this study. A total of 50 patients will be recruited from Emam Khomeiny hospital clinic. These patients will be divided in to two groups (intervention and placebo), each have 25 patients, using block randomization. After signing informed consent form by patients, cyproheptadine will be administered 8 mg per day for one week and 12 mg per day for other 3 weeks in interventional group and patients will take placebo with the same dose and frequency in control group. The patients will be followed for 4 weeks. Neuropsychiatric effects will be evaluated with followed scales on day 0 and 28 after treatment, Hamilton depression and anxiety, beck depression, Pittsburgh Sleep Quality, suicidal thoughts, Symptom Checklist 90, Positive and Negative Syndrome Scale will be assessed and compared in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103106026N1
Registration date:2011-05-01, 1390/02/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-05-01, 1390/02/11
Registrant information
Name
Fatemeh Dabaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5034
Email address
dabaghzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-11-21, 1390/08/30
Expected recruitment end date
2012-09-24, 1391/07/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized placebo controlled trial of cyproheptadine for prevention of neuropsychiatric adverse effects of antiretroviral including efavirenz.
Public title
Cyproheptadine for prevention of neuropsychiatric adverse effects of antiretrovirals including efavirenz
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with HIV-1 infection, older than 18 years who are scheduled to receive an efavirenz-containing treatment
Exclusion criteria:
Pervious treatment with antiretroviral drugs including efavirenz, pregnancy, use of other medications that be effective on patient‘s mood such as methadone and having major psychiatric disorders like depression at the beginning of this study.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services
Street address
Tehran University of Medical Sciences and Health Services, Enghelab ave, Tehran, Iran
City
Tehran
Postal code
Approval date
2011-01-18, 1389/10/28
Ethics committee reference number
89-04-33-11884
Health conditions studied
1
Description of health condition studied
Human immunodeficiency virus [HIV] disease
ICD-10 code
B23
ICD-10 code description
Human immunodeficiency virus [HIV] disease resulting in other conditions
Primary outcomes
1
Description
Neuropsychiatric effects of efavirenz
Timepoint
Before intevention, 4 weeks after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Appetite
Timepoint
Before intevention, 4 weeks after intervention
Method of measurement
Questionnaire
2
Description
Weight
Timepoint
Before intevention, 4 weeks after intervention
Method of measurement
Weight scale
Intervention groups
1
Description
Interventional group: cyproheptadine, oral tablet 4 mg, 2 tablets at night for 1 week.cyproheptadine, oral tablet 4 mg, 3 tablets at night for other 3 weeks
Category
Treatment - Drugs
2
Description
Control group: cyproheptadine placebo, oral tablet 4 mg, 2 tablets at night for 1 week.cyproheptadine placebo, oral tablet 4 mg, 3 tablets at night for other 3 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr.Hossein Khalili
Street address
Tehran, Imam Khomeini hospital, Infection ward
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research,Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences and Health Services, Enghelab Ave, Tehran, Iran
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,Tehran University of Medical Sciences and Health Services
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences and Heal
Full name of responsible person
Hossein Khalili
Position
Phrm.D, BCPS, Associate Professor
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences and Health Services, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
khalilih@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Pharm.D, Resident of clinical pharmacy
Other areas of specialty/work
Street address
Tehran University of Medical Sciences and Health Services, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Fax
Email
fatemeh_dabaghzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)