Studying the effects of Celecoxib as monotherapy in the treatment of postpartum depression with mild intensity to the average: response to treatment of Celecoxib by area Brain-Derived Neurotrophic Factor (BDNF) and inflammatory cytokines (TNFα, IFNγ , IL-1Α, IL-1Β IL-6, IL-8)
Studying the effects of Celecoxib as monotherapy in the treatment of postpartum depression with mild intensity to the average
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
The study will be performed on women with mild to moderate postpartum depression Attending Roozbeh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages of 18 to 45 years - Having mild to moderate depression according to Hamilton Depression Rating Scale (HAM-D or HDRS). Exclusion criteria: Having severe depression according to Hamilton Depression Rating Scale (HAM-D or HDRS) - Addiction to drugs - Addiction to alcohol - Presence of Thyroid disease - Receiving any antidepressant medications during past one month prior to the trial - Receiving Electroconvulsive therapy during past two months prior to the trial - Any other diagnosis according to axis-1, DSM-5 - Having a risk of suicide based on doctor's clinical judgement or having a score of >2 in suicide item of Hamilton Depression Rating Scale (HAM-D or HDRS) - Concomitant use of medications that increase the risk of gastrointestinal bleeding - Presence of cardiovascular disease - Pregnant and lactating women - Risk of child murder
Intervention groups
Women who score below 18 based on Hamilton Depression Rating Scale (HAM-D or HDRS) will be considered as mild to moderate depressed patients and randomly divided into two groups.The intervention group (25 patients) will receive Celecoxib (200 mg BID) for 8 weeks. The control group (25 patients) will receive placebo for 8 weeks (BID).
Main outcome variables
Severity of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N125
Registration date:2020-05-17, 1399/02/28
Registration timing:prospective
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effects of Celecoxib as monotherapy in the treatment of postpartum depression with mild intensity to the average: response to treatment of Celecoxib by area Brain-Derived Neurotrophic Factor (BDNF) and inflammatory cytokines (TNFα, IFNγ , IL-1Α, IL-1Β IL-6, IL-8)
Public title
The effects of Celecoxib in the treatment of postpartum depression with mild intensity to the average
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 45
Having mild to moderate depression according to Hamilton Depression Rating Scale (HAM-D)
Exclusion criteria:
Having severe depression according to Hamilton Depression Rating Scale (HAM-D or HDRS)
Addiction to drugs
Addiction to alcohol
Presence of Thyroid disease
Receiving any antidepressant medications during past one month prior to the trial
Receiving Electroconvulsive therapy during past two months prior to the trial
Any other diagnosis according to axis-1, DSM-5
Having a risk of suicide based on doctor's clinical judgement or having a score of >2 in suicide item of Hamilton Depression Rating Scale (HAM-D or HDRS)
Concomitant use of medications that increase the risk of gastrointestinal bleeding
Presence of cardiovascular disease
Pregnant and lactating women
Risk of child murder
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups)
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.TUMS.VCR.REC.1398.1060
Health conditions studied
1
Description of health condition studied
Postpartum depression
ICD-10 code
O90.6
ICD-10 code description
Postpartum mood disturbance
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline and weeks 2, 4, 6, and 8
Method of measurement
By Hamilton Depression Rating Scale (HAM-D or HDRS)