Major Depressive DisorderPhase 1/2NCT05271084
Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder
A Phase 1/2 study testing Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg in people with Major Depressive Disorder, run by Hawler Medical University at 1 site in Iraq.
Trial summary
The aim of this study is to test if combining the antidepressant Citalopram with Pentoxifylline (PTX), a medicine with anti-inflammatory and phosphodiesterase inhibitory properties, enhanced antidepressant efficacy in adult patients with major depressive disorder (MDD) when compared to Citalopram alone. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 10 Nov 2021to 8 Jun 2022
- Phase
- Phase 1/2
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written, voluntary informed consent prior to study enrollment.
- Male or female between the ages of 21 to 65.
- Patient must be diagnosed with a moderate to a severe depressive episode, as determined by the MADRS score >21.
- Prior to taking part in the trial, all patients were requested to abstain from all psychotropic and anti-inflammatory medications for at least four weeks.
Who cannot join
- Current psychotic symptoms or perceptual problems of any kind, at the discretion of the investigator
- The presence of a contraindication to PTX, such as a drug allergy or xanthine derivative allergy
- The presence of cardiovascular diseases, including high blood pressure, a recent myocardial infarction, cardiac arrhythmia, coronary artery disease, or a coagulation disorder
- Renal impairment, defined as creatinine clearance less than 80ml/min
- Patients who have previously received electroconvulsive therapy (ECT)
- Patients who have inflammatory disorders
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- Patients with a concurrent active medical condition
- Patients with a history of seizures
- Patients who are pregnant or nursing females.
- Patients with bipolar I or bipolar II disorder
- Patients with personality disorders
- Patients with eating disorders
- Patients with substance dependence or abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial
The aim of this study is to test if combining the antidepressant Citalopram with Pentoxifylline (PTX), a medicine with anti-inflammatory and phosphodiesterase inhibitory properties, enhanced antidepressant efficacy in adult patients with major depressive disorder (MDD) when compared to Citalopram alone.
Read the detailed description
According to mounting evidence, inflammation and phosphodiesterase (PDE) pathways may play a role in the pathogenesis of psychiatric diseases such as MDD. PTX is a phosphodiesterase inhibitor and has anti-inflammatory and antioxidant effects. Therefore, it has been hypothesized that MDD patients taking combined administration of the Citalopram, a Selective Serotonin Reuptake Inhibitor (SSRI), and PTX would show a higher improvement in depression symptoms. The relationship between the Hamilton Depression Rating Scale-17 items (Ham-D-17) score and various biological markers and their potential role in the therapeutic outcome of MDD will be assessed.
- Conditions
- Major Depressive Disorder
- Being tested
- Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg, Citalopram (tablet) 20 mg + Placebo (tablet)
- 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.
Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400MgDrug
Selective serotonin reuptake inhibitor (SSRI) + phosphodiesterase inhibitor with anti-inflammatory properties
Citalopram (tablet) 20 mg + Placebo (tablet)Drug
Selective serotonin reuptake inhibitor (SSRI) + placebo
| Study group | Role | What they receive |
|---|---|---|
| Citalopram + Pentoxifylline group | Experimental | Citalopram (tablet): 20 mg once a day for 12 weeks + Pentoxifylline (tablet): 400 mg twice a day for 12 weeks Receives: Drug: Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg |
| Control group | Placebo comparator | Citalopram (tablet): 20 mg once a day for 12 weeks + placebo (tablet) twice a day for 12 weeks Receives: Drug: Citalopram (tablet) 20 mg + Placebo (tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale 17 (HDRS-17) Scores (Time Frame: Baseline, week 2,4,6,8,10, and12)
The HDRS is a 17-item scale that asks participants to rate the severity of their depression symptoms. Scoring is based on the 17-item scale. The total score ranges from 0 to 52, with higher numbers demonstrating more severe symptoms. Normal scores range from 0 to 7, mild depression ranges from 8 to 16, moderate depression ranges from 17 to 23, and scores of 24 and greater indicate severe depression. Remission is defined as HDRS total score ≤ 7 (primary outcome).
Measured: 12 weeks
Secondary outcomes (7)
Effect on the serum level of tumor necrosis factor-alpha (TNF-α)
Peripheral blood samples will be obtained and serum levels of TNF-α ( pg/mL) will be measured at baseline and after treatment (week 12)
Measured: 12 weeks
Effect on the serum level of circulating C-reactive protein (CRP)
Peripheral blood samples will be obtained and serum levels of CRP (mg/dL) will be measured at baseline and after treatment (week 12)
Measured: 12 weeks
Effect on the serum level of interleukin 6 (IL-6)
Peripheral blood samples will be obtained and serum levels of IL-6 (pg/mL) will be measured at baseline and after treatment (week 12)
Measured: 12 weeks
Effect on the serum level of interleukin-1-β (IL-1-β)
Peripheral blood samples will be obtained and serum levels of IL-1-β (pg/mL) will be measured at baseline and after treatment (week 12)
Measured: 12 weeks
Effect on the serum level of interleukin-10 (IL-10)
Peripheral blood samples will be obtained and serum levels of IL-10 (pg/mL) will be measured at baseline and after treatment (week 12)
Measured: 12 weeks
Effect on the serum level of brain derived neurotrophic factor (BDNF)
Peripheral blood samples will be obtained and serum levels of BDNF (ng/mL) will be measured at baseline and after treatment (week 12)
Measured: 12 weeks
Effect on the serum level of serotonin
Peripheral blood samples will be obtained and serum levels of serotonin (ng/mL) will be measured at baseline and after treatment (week 12)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start10 Nov 2021
- Primary completion25 Feb 2022
- Study completion8 Jun 2022
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talar A. Merza Mohammad, Hawler Medical University
- Investigators
- Talar A Merzamohammad, Pharm. D, Principal investigator, Hawler Medical University, College of Pharmacy, Department of Pharmacology and Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271084
- Sponsor's protocol ID
- HMU PE-EC 16112021/382
- Status last verified
- Sep 2022
- First submitted
- 23 Feb 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05271084
- Acronym / sponsor ID
- HMU PE-EC 16112021/382
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 8 Mar 2022 (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.
The aim of this study is to test if combining the antidepressant Citalopram with Pentoxifylline (PTX), a medicine with anti-inflammatory and phosphodiesterase inhibitory properties, enhanced antidepressant efficacy in adult patients with major depressive disorder (MDD) when compared to Citalopram alone.
Detailed description
According to mounting evidence, inflammation and phosphodiesterase (PDE) pathways may play a role in the pathogenesis of psychiatric diseases such as MDD. PTX is a phosphodiesterase inhibitor and has anti-inflammatory and antioxidant effects. Therefore, it has been hypothesized that MDD patients taking combined administration of the Citalopram, a Selective Serotonin Reuptake Inhibitor (SSRI), and PTX would show a higher improvement in depression symptoms. The relationship between the Hamilton Depression Rating Scale-17 items (Ham-D-17) score and various biological markers and their potential role in the therapeutic outcome of MDD will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citalopram + Pentoxifylline group | Experimental | Drug: Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400MgCitalopram (tablet): 20 mg once a day for 12 weeks + Pentoxifylline (tablet): 400 mg twice a day for 12 weeks |
| Control group | Placebo comparator | Drug: Citalopram (tablet) 20 mg + Placebo (tablet)Citalopram (tablet): 20 mg once a day for 12 weeks + placebo (tablet) twice a day for 12 weeks |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide written, voluntary informed consent prior to study enrollment.
- Male or female between the ages of 21 to 65.
- Patient must be diagnosed with a moderate to a severe depressive episode, as determined by the MADRS score >21.
- Prior to taking part in the trial, all patients were requested to abstain from all psychotropic and anti-inflammatory medications for at least four weeks.
Key exclusion criteria (13 listed)
- Current psychotic symptoms or perceptual problems of any kind, at the discretion of the investigator
- The presence of a contraindication to PTX, such as a drug allergy or xanthine derivative allergy
- The presence of cardiovascular diseases, including high blood pressure, a recent myocardial infarction, cardiac arrhythmia, coronary artery disease, or a coagulation disorder
- Renal impairment, defined as creatinine clearance less than 80ml/min
- Patients who have previously received electroconvulsive therapy (ECT)
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 |
|---|---|---|
| Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400MgSelective serotonin reuptake inhibitor (SSRI) + phosphodiesterase inhibitor with anti-inflammatory properties | Drug | Citalopram + Pentoxifylline group |
| Citalopram (tablet) 20 mg + Placebo (tablet)Selective serotonin reuptake inhibitor (SSRI) + placebo | Drug | Control group |
Primary outcome
Hamilton Depression Rating Scale 17 (HDRS-17) Scores (Time Frame: Baseline, week 2,4,6,8,10, and12)
Time frame: 12 weeks
The HDRS is a 17-item scale that asks participants to rate the severity of their depression symptoms. Scoring is based on the 17-item scale. The total score ranges from 0 to 52, with higher numbers demonstrating more severe symptoms. Normal scores range from 0 to 7, mild depression ranges from 8 to 16, moderate depression ranges from 17 to 23, and scores of 24 and greater indicate severe depression. Remission is defined as HDRS total score ≤ 7 (primary outcome).
7 secondary outcomes
Effect on the serum level of tumor necrosis factor-alpha (TNF-α)
Time frame: 12 weeks
Effect on the serum level of circulating C-reactive protein (CRP)
Time frame: 12 weeks
Effect on the serum level of interleukin 6 (IL-6)
Time frame: 12 weeks
Effect on the serum level of interleukin-1-β (IL-1-β)
Time frame: 12 weeks
Effect on the serum level of interleukin-10 (IL-10)
Time frame: 12 weeks
Effect on the serum level of brain derived neurotrophic factor (BDNF)
Time frame: 12 weeks
Effect on the serum level of serotonin
Time frame: 12 weeks
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 7 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Talar A Merzamohammad, Pharm. D principal investigator
Hawler Medical University, College of Pharmacy, Department of Pharmacology and Toxicology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg in people with Major Depressive Disorder, run by Hawler Medical University at 1 site in Iraq.
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 4 inclusion and 13 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hamilton Depression Rating Scale 17 (HDRS-17) Scores (Time Frame: Baseline, week 2,4,6,8,10, and12) (time frame: 12 weeks). 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 7 Sep 2022.