The aim of this study is to assess the efficacy of Nepeta menthoides as an antidepressant agent in major depression treatment, in a 6 week randomized double-blind controlled trial. A total of 60 adult outpatients between 18-65 ages referring to psychiatry clinic of Shiraz medical university, who meet Becks depression inventory (BDI-II) and DSM-V-TR criteria for major depression and their diagnosis is confirmed by at least two psychiatrists are randomly allocated into two groups (30 patients in each) and assign to receive 400 mg of dried powdery formation of a traditional decoction from Nepeta menthoides or 50 mg of sertraline in the uniformed capsules twice daily (in the morning and 1-2 hours before sleeping time at night). Patients who may have other conditions assuming depression such as hypothyroidism, psychiatric disorders except for major depression, mental disorders such as dementia or mental retardation, allergy to Nepeta menthoides or other Mint family (Lamiaceae) plants, substance dependency, pregnancy, suicidal thinking or needing to electroconvulsive therapy or not having informed consent are excluded. Severity of depression and anxiety (by Beck inventory for depression and anxiety) and also common possible side effects of drugs will assess in baseline, 2nd week, 4th week and then two weeks after the end of the intervention (in 6th week)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031521469N1
Registration date:2015-06-03, 1394/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-03, 1394/03/13
Registrant information
Name
Sepideh Kolouri
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 2988
Email address
kolouri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Shiraz University of Medical Science
Expected recruitment start date
2015-04-07, 1394/01/18
Expected recruitment end date
2015-07-07, 1394/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Nepeta mentoithes Boiss & Bohse and a common anti depressant drug (Sertraline) in mild to moderate major depression
Public title
Efficacy of Nepeta Menthoides in depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Adult outpatients between 18-65 referring to psychiatry clinic of Shiraz medical university; meet Becks depression inventory (BDI-II) and DSM-V-TR criteria for mild to moderate major depression; confirmation of the diagnosis by at least two psychiatrist; and informed consent.
Exclusion criteria: Having other conditions assuming depression such as: hypothyroidism, psychiatric disorders except for mild to moderate major depression, mental disorders i.e. dementia
or mental retardation; allergy to Nepeta Menthoides or other mentheae family (Lamiaceaes); substance dependency; pregnancy; suicidal thinking or needing to electroconvulsive therapy; not having informed consent
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Blocked randomization; Blinding with use of Sertraline in the same capsules for control group, all capsules are similar in size and colour, boxes in which capsules pack have the same shape in both groups. Patients and researcher who evaluate study out comes and even though the data analyzer are blind and do not know which group receives Sertraline or Nepeta .
Secondary Ids
1
Registry name
Iranian Registry of Clinical Trial
Secondary trial Id
CT- 9470 - 7440
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shiraz University of Medical Science
Street address
Vice chancellor for research and technology office, Shiraz University of Medical Science, Zand street,Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2015-04-07, 1394/01/18
Ethics committee reference number
CT-9470-7440
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0, F32
ICD-10 code description
Mild depressive episode, moderate depressive episode, recurrent depressive disorder current episode mild, recurrent depressive disorder current episode moderate
2
Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
severity of depression
Timepoint
At the base line,2nd week, 4th week after beginning of intervention and then in 6th week (2 weeks after the end of intervention)
Method of measurement
Beck depression inventory(BDI-II) score
Secondary outcomes
1
Description
Side effects profile
Timepoint
At the base line, 2nd week, 4th week after beginning of intervention and then in 6th week (2 weeks after the end of intervention)
Method of measurement
Clinical interview and physical examination and list in a table
2
Description
Severity of anxiety
Timepoint
At the base line, 2nd week, 4th week after beginning of intervention and then in6th week (2 weeks after the end of intervention)
Method of measurement
Beck anxiety inventory (BAI) score
Intervention groups
1
Description
One 400 mg oral capsule from Nepeta menthoides aerial parts freeze-dried water extract (extract concentration, 10%), twice daily (one in morning half hour before breakfast and one at night 1-2 hour before usual sleep time) for one month
Category
Treatment - Drugs
2
Description
Serteraline (Sertrabiol manufactured by Bakhtar Bioshimi Co.) , 50 mg in each capsule, one capsule twice daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Psychiatry Clinic
Full name of responsible person
Sepideh koloury
Street address
Hafez Hospital, Chamran Blvd., Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Emamreza clinic
Full name of responsible person
Sepideh koloury
Street address
Namazi Sq., Zand St., Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Science
Full name of responsible person
Dr.Seyed Basir Hashemi
Street address
Vice chancellor for research and technology, Shiraz University of Medical Science
City
Shiraz
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, Shiraz University of Medical Science
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
Shiraz University of Medical Science
Full name of responsible person
Sepideh Koloury
Position
MD, PhD candidate in Traditional Medicine
Other areas of specialty/work
Street address
Traditional Persian Medicine college, School of Medicine, Imam Hossein Sq., Zand St., Shiraz
City
Shiraz
Postal code
7194647989
Phone
+98 71 3233 7589
Fax
+98 71 3233 8476
Email
kolouri@sums.ac.ir, sepidehkolouri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Ali Firoozabadi
Position
Psychiatrist, Associated professor
Other areas of specialty/work
Street address
Shiraz Department of psychiatry, Hafez hospital, Chamran Blvd., Shiraz
City
Shiraz
Postal code
71946-34786
Phone
+98 71 3627 9319
Fax
+98 71 3627 9319
Email
firooza@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Sepideh kolouri
Position
MD.PhD candidate in Traditional Medicine
Other areas of specialty/work
Street address
Traditional Persian Medicine college, School of Medicine, Imam Hossein Sq., Zand St., Shiraz
City
Shiraz
Postal code
7194647989
Phone
+98 71 3627 2988
Fax
+98 71 3233 8476
Email
kolouri@sums.ac.ir, sepidehkolouri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)