A comparison of tricyclic antidepressant augmentation with herbal formation Hypericum perforatum and placebo in depressed outpatients referred to psychiatric clinic and Golestan hospital / Ahvaz /Iran
The aim of this double blind study the therapeutic effects of medicinal products with Hypericum is an antidepressant. 40 depressed patients referred to psychiatric clinic with a diagnosis of depression based on TR DSM-IV criteria for diagnosis are studied. Patients randomly divided into two groups and a group of tricyclic antidepressants in treating depression and a range of moderate Hypericum tablets three times daily for 6 weeks and another group tricyclic antidepressants in the range of moderate depression and a number placebo tablets three times daily for 6 weeks received. Before intervention and at three and six weeks with a severely depressed therapist measured by Beck Depression Inventory and the two groups are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010124917N1
Registration date:2011-01-20, 1389/10/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-20, 1389/10/30
Registrant information
Name
Sirus Pakseresht
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1338 3124
Email address
pakseresht@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of tricyclic antidepressant augmentation with herbal formation Hypericum perforatum and placebo in depressed outpatients referred to psychiatric clinic and Golestan hospital / Ahvaz /Iran
Public title
Therapeutic effect of herbal formulation Hypericum perforatum with antidepressant drug
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Major depressive disorder diagnosed by a psychiatrist based on DSM-IV-TR criteria, age range between 18-55 years, filling the consent form, mild or moderate severity of depression
Exclusion Criteria: Pregnancy, breast feeding, organic or neurological disorder featuring both clinically, Axis II psychiatric disorder, presence of simultaneous psychiatric disorder diagnosis in axis I, using alcohol and other addictive substances other than nicotine and caffeine in a one-month past, exacerbation of symptoms of severe depression or psychotic disorders, Signs that require hospitalization and emergency action such as suicidal thoughts and behaviors, Not receiving ECT over three months prior to the study, any particular sensitivity to plant grass herbal tea, consumption of medicine such as lithium, anticonvulsants, sumatriptan, Al Biped, serotonin-reuptake inhibitors, buspirone, Argo compounds, Selegiline, stimulants, anti-congestive, contraceptives, cimetidine, theophylline or thyroid hormones during 7 days prior to the 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:
40
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
Ahvaz Jundishapur Univercity of Medical Sciences
Street address
Golestan boulevard
City
Ahvaz
Postal code
Approval date
2010-04-18, 1389/01/29
Ethics committee reference number
339//20/8/پ
Health conditions studied
1
Description of health condition studied
Moderate depression
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode
2
Description of health condition studied
Mild depression
ICD-10 code
F 32.0
ICD-10 code description
Mild depressive episode
Primary outcomes
1
Description
Improvement of sleep
Timepoint
3 weeks
Method of measurement
clinical interview
2
Description
improvement of apetite
Timepoint
3 weeks
Method of measurement
clinical interview
Secondary outcomes
1
Description
treatment of depression
Timepoint
3 weeks
Method of measurement
Beck Rating Scale for Depression
Intervention groups
1
Description
Tricyclic antidepressant with average dose, as well as Hypericum Perforatum (a herbal formulation), three times a day 6 weeks
Category
Treatment - Drugs
2
Description
Tricyclic antidepressant with average dose, as well as placebo, three times a day 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
psychiatric clinic
Full name of responsible person
Street address
City
Ahvaz
2
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Golestan Blv
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, 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
Dr. Zhale Nilsaz
Position
Psychiatric Assistant
Other areas of specialty/work
Street address
Unit 3, Number 9, East Elham St., Kianpars
City
Ahvaz
Postal code
Phone
+98 61 1333 8770
Fax
Email
drbabapour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Sirus Pakseresht
Position
Psychiatric Professor Assistant
Other areas of specialty/work
Street address
Unit 5, Number 110, sixth St., Kianpars west
City
Ahvaz
Postal code
Phone
+98 61 1338 3124
Fax
Email
Pakseresht@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
Dr. Zhale Nilsaz
Position
Psychiatric Assistant
Other areas of specialty/work
Street address
Unit 3, Number 9, East Elham St., Kianpars
City
Ahvaz
Postal code
Phone
+98 61 1333 8770
Fax
Email
drbabapour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)