Protocol summary
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Study aim
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The objective of this study is to assess the efficacy of pentoxifylline in the treatment of MDD
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Design
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Randomized double blind and placebo-controlled clinical trial
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Settings and conduct
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The study will be conducted among adults with major depressive disorder attending Roozbeh Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: presence of Major Depressive Disorder based on DSM-5 criteria; baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 19.
Exclusion criteria: presence of psychosis, any other mental disorder; presence of hypothyroidism or cardiovascular problems; pregnancy or nursing women; hepatic failure; peptic ulcer; receiving antiplatelets agents or anticoagulants; receiving NSAIDs.
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Intervention groups
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The participants will be randomly allocated into two groups. Intervention group(25 persons) will receivepentoxyfylline (400 mg TDS) and sertraline ( 50 mg per day) and control group ( 25 persons) will receive sertraline ( 50 mg per day) for 6 weeks.
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Main outcome variables
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Severity of depression
General information
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Reason for update
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Change in the dosage of Serteralin from 50 mg to 100 mg
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090117001556N116
Registration date:
2019-03-14, 1397/12/23
Registration timing:
prospective
Last update:
2020-08-25, 1399/06/04
Update count:
1
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Registration date
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2019-03-14, 1397/12/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-04-13, 1398/01/24
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Expected recruitment end date
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2021-04-12, 1400/01/23
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Pentoxifylline as adjuvant therapy in the treatment of major depression: a randomised and double blind study
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Public title
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Pentoxifylline as adjuvant therapy in the treatment of major depression
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Presence of Major Depressive Disorder based on DSM-5 criteria
Baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 19
Exclusion criteria:
Presence of psychosis
Any other mental disorder
Hypothyroidism
Cardiovascular disease
Pregnancy or nursing women
Renal failure
Allergy to Theophylline, Aminophylline, and pentoxyfylline
Hepatic failure
Peptic ulcer
Receiving antiplatelets agents or anticoagulants
Receiving NSAIDs
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random permuted block
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The participants, clinicians and outcome raters will be blind regarding grouping
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-03-11, 1397/12/20
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Ethics committee reference number
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IR.TUMS.VCR.REC.1397.1006
Health conditions studied
1
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Description of health condition studied
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Major Depressive Disorder
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ICD-10 code
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F32.1
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ICD-10 code description
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Major depressive disorder, single episode, moderate
Primary outcomes
1
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Description
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Severity of depression
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Timepoint
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Baseline and weeks 2,4 and 6
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Method of measurement
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By Hamiltion Depression Rating Scale 17-Item
Intervention groups
1
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Description
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Intervention group: tablet sertralin 100 mg/day plus Capsule pentoxyfylline 400 mg TDS as intervention group for 6 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: tablet sertralin 100 mg/day plus Capsule placebo as control group for 6 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The data will be distributed through final report
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When the data will become available and for how long
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5 years from 2021 to 2026
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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by citing the resourse
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From where data/document is obtainable
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Professor Shahin Akhondzadeh
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What processes are involved for a request to access data/document
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by E mail
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Comments
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