Major Depressive DisorderNCT03554447
Role of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder
A study testing Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet in people with Major Depressive Disorder, run by Mahmoud Samy Abdallah.
Trial summary
This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase inhibition activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
- Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.
Who cannot join
- Patients with bipolar I or bipolar II disorder
- Patients with personality disorders
- Patients with eating disorders
- Patients with substance dependence or abuse
- Patients with concurrent active medical condition
- Patients with history of seizures
Show all 10Show fewer
- Patients with history of receiving Electroconvulsive therapy (ECT)
- Patients with inflammatory disorders
- Patients with allergy or contraindications to the used medications
- Patients with finally pregnant or lactating females
About this study
Official title: Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial.
This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase inhibition activities.
Read the detailed description
In this study, the investigators evaluated the potential antidepressant effect of PTX in adult patients with MDD. the investigators hypothesized that MDD patients taking add-on PTX would present greater amelioration of their depressive symptoms than patients taking add-on placebo. Furthermore, the investigators assessed the relationship between HAM-D score and several peripheral biomarkers as well as their role in diagnosis and therapeutic targets of MDD.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet, Escitalopram 20 mg tablet + Placebo
- Keywords
- Pentoxifylline, Anti-inflammatory, MDD, phosphodiastrase inhibitors
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram 20 mg tablet plus Pentoxifylline 400Mg TabletDrug
Selective serotonin reuptake inhibitor plus phosphodiesterase inhibitor with anti-inflammatory properties
Escitalopram 20 mg tablet + PlaceboDrug
Selective serotonin reuptake inhibitor plus placebo
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline group | Experimental | Escitalopram 20 mg tablet once daily for 12 week plus Pentoxifylline 400 mg tablet twice daily for 12 weeks Receives: Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet |
| Control group | Placebo comparator | Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks Receives: Drug: Escitalopram 20 mg tablet + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on Hamilton Depression rating scale score (HAM-D score)
The principal measure of the outcome was the 17-items HAM-D. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-13 suggest mild depression, 14-17 moderate depression and scores over 17 are indicative of severe depression. Remission is defined as HAM-D total score ≤ 7 (primary outcome). Treatment response is defined as ≥ 50% drop in the HAM-D total score.
Measured: 12 week
Secondary outcomes (1)
Effect on biological markers
Serum level of tumor necrosis factor alpha (TNF-α), Interleukin-6 (IL-6), Interleukin-10 (IL-10), brain derived neurotrophic factor (BDNF), 8-hydroxy-2'-deoxyguanosine (8-OHdG), and serotonin were measured at the baseline and after the treatment to evaluate the biological effects of the used medications.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start20 Apr 2015
- Primary completion1 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Samy Abdallah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Samy Abdallah, Sadat City University
- Investigators
- Sahar El-Haggar, Ph.D, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554447
- Sponsor's protocol ID
- 0074/2015
- Status last verified
- Jun 2020
- First submitted
- 31 May 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT03554447
- Acronym / sponsor ID
- 0074/2015
- Conditions
- Major Depressive Disorder
- Keywords
- Pentoxifylline, Anti-inflammatory, MDD, phosphodiastrase inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mahmoud Samy AbdallahUniversity, hospital or other
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase inhibition activities.
Detailed description
In this study, the investigators evaluated the potential antidepressant effect of PTX in adult patients with MDD. the investigators hypothesized that MDD patients taking add-on PTX would present greater amelioration of their depressive symptoms than patients taking add-on placebo. Furthermore, the investigators assessed the relationship between HAM-D score and several peripheral biomarkers as well as their role in diagnosis and therapeutic targets of MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline group | Experimental | Drug: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg TabletEscitalopram 20 mg tablet once daily for 12 week plus Pentoxifylline 400 mg tablet twice daily for 12 weeks |
| Control group | Placebo comparator | Drug: Escitalopram 20 mg tablet + PlaceboEscitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
- Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.
Key exclusion criteria (10 listed)
- Patients with bipolar I or bipolar II disorder
- Patients with personality disorders
- Patients with eating disorders
- Patients with substance dependence or abuse
- Patients with concurrent active medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram 20 mg tablet plus Pentoxifylline 400Mg TabletSelective serotonin reuptake inhibitor plus phosphodiesterase inhibitor with anti-inflammatory properties | Drug | Pentoxifylline group |
| Escitalopram 20 mg tablet + PlaceboSelective serotonin reuptake inhibitor plus placebo | Drug | Control group |
Primary outcome
Effect on Hamilton Depression rating scale score (HAM-D score)
Time frame: 12 week
The principal measure of the outcome was the 17-items HAM-D. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-13 suggest mild depression, 14-17 moderate depression and scores over 17 are indicative of severe depression. Remission is defined as HAM-D total score ≤ 7 (primary outcome). Treatment response is defined as ≥ 50% drop in the HAM-D total score.
1 secondary outcome
Effect on biological markers
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahar El-Haggar, Ph.D study director
Tanta University
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet in people with Major Depressive Disorder, run by Mahmoud Samy Abdallah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on Hamilton Depression rating scale score (HAM-D score) (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.