Evaluation & comparison of the side effects of Pregabalin & Gabapentin in patients with psychiatric disorders.
Design
Randomized clinical trial with parallel groups.
Settings and conduct
The research is performed in patients referring to the psychology department of Taleghani hospital and Imam Hossein Hospital affiliated to Shahid Beheshti University of Medical Sciences based on the standard questionnaire. Patients are divided into two groups receiving Pregabalin and Gabapentin, and side effects are assessed at 1-month intervals.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women or men with anxiety or depression disorders aged 18 to 65 years; consenting to enter the research. Their medication can include sertraline 50 to 100 mg, citalopram 20 to 40 mg, or citalopram 10 mg.
Exclusion criteria: Refusing to complete the questionnaire. The person getting divorced or menopause. Taking any other medication or dosage other than the above-mentioned dose. Pregnancy or lactation. The person having substance abuse during the study. being allergic to pregabalin and gabapentin.
Intervention groups
Intervention Group 1: Pregabalin recipients. Intervention group 2: Gabapentin recipients.
Main outcome variables
The incidence of the side effects of the two drugs.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003210N23
Registration date:2021-09-01, 1400/06/10
Registration timing:registered_while_recruiting
Last update:2021-09-01, 1400/06/10
Update count:0
Registration date
2021-09-01, 1400/06/10
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-13, 1400/05/22
Expected recruitment end date
2021-08-13, 1400/05/22
Actual recruitment start date
2021-08-14, 1400/05/23
Actual recruitment end date
2022-01-13, 1400/10/23
Trial completion date
2022-03-16, 1400/12/25
Scientific title
Evaluation and comparison of side effects of Pregabalin and Gabapentin in patients with Psychiatric disorders.
Public title
Evaluation and comparison of side effects of Pregabalin and Gabapentin in patients with Psychiatric disorders.
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 65 years old.
Suffering from depression or anxiety.
Taking Sertraline (50-100mg) or Citalopram (20-40mg) or Escitalopram (10mg).
Consent to enter the research.
Be married.
Exclusion criteria:
Refusing to fill the questionnaire.
Getting divorced or reaching menopause
Taking medications other than those listed.
Pregnancy or lactation.
Having substance abuse during the study.
Being allergic to Pregabalin or Gabapentin.
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
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 Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Street address
The SBMU school of pharmacy, Valiasr St., Niayesh cross section, Tehran
City
Tehran
Province
Tehran
Postal code
1991953381
Approval date
2019-11-10, 1398/08/19
Ethics committee reference number
1398.222.IR.SBMU.PHARMACY.REC
Health conditions studied
1
Description of health condition studied
Anxiety disorder
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Depressive disorder
ICD-10 code
F06.32
ICD-10 code description
Mood disorder due to known physiological condition with major depressive-like episode
Primary outcomes
1
Description
Sexual Dysfunctions
Timepoint
One Month
Method of measurement
The International Index of Erectile function Questionnaire; The Female Sexual Function Index Questionnaire
2
Description
Drowsiness
Timepoint
One Month
Method of measurement
Questionnaire
3
Description
Dizziness
Timepoint
One Month
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: The first group will receive 75 to 150 mg of oral pregabalin per day.
Category
Treatment - Drugs
2
Description
Second intervention group: Patients in this group will receive 100 to 600 mg of oral gabapentin per day.