Evaluation of the effectiveness of omega-3 fatty acid supplementation compared with placebo in the treatment of patients with mood disorders caused by methamphetamine
Study of the effectiveness of omega-3 fatty acid supplementation compared with placebo in the treatment of patients with mood disorders caused by methamphetamine
Design
In this double-blind clinical trial with parallel groups (intervention and a control) the researcher and the patients will be aware of participation in the study and probability of receiving a new medication but the researcher and the participant will be kept blinded about allocation to each group. In this phase 2-3 randomized study, at least 50 patients with mood disorders will participate. A random number table will be used for randomization.
Settings and conduct
This double-blind study will be conducted in Farabi hospital, Kermanshah. TLC test will be performed to confirm methamphetamine use, and based on a structured DSM-VI interview, a psychiatrist must confirm the diagnosis of methamphetamine-induced mood disorder.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of methamphetamine-induced mood disorders based on DSM5 diagnostic criteria.
Exclusion criteria: Simultaneous use of other substances; History of primary mood disorders; History of brain disorders; People with certain diseases and kidney patients; People with blood clotting problems
Intervention groups
Intervention group: In addition to standard treatment, the intervention group will receive 30 capsules containing 1 gram of omega-3 for 8 weeks (1 capsule daily).
Control group: In addition to standard treatment, the control group will receive 30 capsules containing 1 gram of placebo for 8 weeks (1 capsule daily).
Main outcome variables
Recurrence rate; Temptation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N161
Registration date:2021-03-08, 1399/12/18
Registration timing:registered_while_recruiting
Last update:2021-03-08, 1399/12/18
Update count:0
Registration date
2021-03-08, 1399/12/18
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of omega-3 fatty acid supplementation compared with placebo in the treatment of patients with mood disorders caused by methamphetamine
Public title
The effect of omega-3 fatty acids in the treatment of patients with mood disorders caused by methamphetamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of methamphetamine-induced mood disorders based on DSM5 diagnostic criteria
Exclusion criteria:
Simultaneous use of other substances
History of primary mood disorders
History of brain disorders
People with certain diseases and kidney patients
People with blood clotting problems
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients will be divided into two groups of 25. Each patient will be assigned a 4-digit code based on the random number table, Based on the right number of patients' code, the patients will be divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blinded study, the researcher and the patient do not know who will receive the new drug. Patients will be aware of the participation in the study, but the researcher and the participant will be kept blinded to which group will receive the new medicine and which group will receive the placebo. The placebo and the new drug are both in the same capsule form, kept in the same container. Drugs can only be identified by the serial number on the container.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
ir.kums.rec.1399.808
Health conditions studied
1
Description of health condition studied
Mood disorders
ICD-10 code
F31.32
ICD-10 code description
Bipolar disorder, current episode depressed, moderate
2
Description of health condition studied
Methamphetamine Dependency
ICD-10 code
F15.15
ICD-10 code description
Other stimulant abuse with stimulant-induced psychotic disorder
Primary outcomes
1
Description
Recurrence rate
Timepoint
Beginning of the study, end of the fourth week, end of the eighth week
Method of measurement
Based on recurrence questionnaire (RPS)
2
Description
Temptation
Timepoint
Beginning of the study, end of the fourth week, end of the eighth week
Method of measurement
Based on the temptation questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group,in addition to standard treatment, will receive 30 capsules containing 1 gram of omega-3 for 8 weeks (1 capsule daily).
Category
Treatment - Drugs
2
Description
The control group, in addition to standard treatment, will receive 30 capsules containing 1 gram of placebo for 8 weeks (1 capsule daily).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Dr. Faezeh Tatari
Street address
Isar Square, Dolatabad Boulevard, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1046
Email
fztatari37@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nona Vaezi
Position
Resident of psychiatric
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Isar Square, Dolatabad Boulevard, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1046
Email
Amirvaezi007@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Faezeh Tatari
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Isar Square, Dolatabad Boulevard, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1046
Email
fztatari37@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nona Vaezi
Position
Resident of psychiatric
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Isar Square, Dolatabad Boulevard, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1046
Email
Amirvaezi007@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available