To assess the effectiveness, safety and side effects of three drugs- escitalopram, fluoxetine and vitagnus- in premenstrual dysphoric disorder
Design
Parallel groups randomized clinical trial with control group
Settings and conduct
In this randomized clinical trial 75 premenstrual dysphoric disorder patients whose disease will be confirmed by the study psychiatrist, based on diagnostic criteria of psychiatric disorders will be allocated randomly in two intervention groups and one control group. These patients will be examined at the end of the first, second and the third month of intervention and the effectiveness and safety of prescribed drugs will be assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmed diagnosis of premenstrual dysphoric disorder; To have regular menstrual periods; Assignment the informed consent form of the study
Exclusion criteria: Polycystic ovarian disease; Serious psychiatric disorders; and Breast feeding
Intervention groups
Intervention group 1: Escitalopram manufactured in Abidi´s Pharmaceutical Company 10 milligram per day for three months; Intervention group 2: Vitagnus tablets manufactured in Poursina Pharmaceutical Company 20 milligram per day for three months; Control group: Fluoxetine manufactured in Abidi´s Pharmaceutical Company 20 milligram per day for three months
Main outcome variables
The severity of premenstrual symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150630022991N13
Registration date:2018-10-12, 1397/07/20
Registration timing:registered_while_recruiting
Last update:2018-10-12, 1397/07/20
Update count:0
Registration date
2018-10-12, 1397/07/20
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness and side effects of three drugs- escitalopram, fluoxetine and vitagnus- in premenstrual dysphoric disorder
Public title
Escitalopram, fluoxetine and vitagnus in premenstrual dysphoric disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of premenstrual dysphoric disorder
To have regular menstrual periods
Assignment the informed consent form of the study
Exclusion criteria:
Polycystic ovarian disease
Irregular menstrual periods
Psychiatric disorders: dementia, psychosis, mental retardation, opium or psychoactive drugs abuse and high mood
Breast feeding
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
In order to random allocation of patients into the three groups of citalopram, fluoxetine and vitagnus, block randomization will be conducted. The free website of www.randomization.com is used to provide the sequence of allocation. The resulting sequence is written in separate sheets and placed in closed envelopes. These will be delivered to the chief researcher to conduct the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4136747176
Approval date
2018-07-08, 1397/04/17
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.093
Health conditions studied
1
Description of health condition studied
Premenstrual dysphoric disorder
ICD-10 code
F38.8
ICD-10 code description
Other specified mood [affective] disorders
Primary outcomes
1
Description
The severity of premenstrual symptoms
Timepoint
At baseline (before initiation of the intervention) and at the end of the first, second and third months after the intervention
Method of measurement
Premenstrual Syndrome Diary (PMSD) questionnaire
Secondary outcomes
1
Description
The presence of psychologic symptoms
Timepoint
Before intervention and at the end of the third month after intervention
Method of measurement
Revised 90- Scale Symptom Checklist (SCL-90-R)
Intervention groups
1
Description
Intervention group 1: Escitalopram manufactured in Abidi´s Pharmaceutical Company 10 milligram per day for three months
Category
Treatment - Drugs
2
Description
Intervention group 2: Vitagnus tablets manufactured in Poursina Pharmaceutical Company 20 milligram per day for three months
Category
Treatment - Drugs
3
Description
Control group: Fluoxetine manufactured in Abidi´s Pharmaceutical Company 20 milligram per day for three months