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Resistant Major DepressionPhase 1/2NCT05324735

Pentoxifylline for Treatment of Resistant Major Depression

A Phase 1/2 study testing Pentoxifylline in people with Resistant Major Depression, run by Hawler Medical University at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A growing body of evidence has highlighted the role of inflammation and phosphodiesterases (PDE)-related pathways in the pathogenesis of neuropsychiatric illnesses such as depression/mood disorders. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Resistant Major Depression
What is being tested?
Pentoxifylline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteIraq
Study dates
15 Dec 2021to 4 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 18 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 18 to 65.
  • Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) criteria for bipolar I or II, currently experiencing a major depressive episode. A Mini-International Neuropsychiatric Interview (MINI) conducted by physician was used to confirm the diagnosis.
  • Meets the criteria for treatment resistant depression (TRD) defined by failure to respond to of at least two treatment trials (antidepressant regimen or electroconvulsive therapy) during the current depressive episode.
  • Prior to taking part in the trial, all patients were requested to be antidepressant free for 4 weeks or to be on a fixed psychotropic therapeutic regimen for at least 4 weeks.

Who cannot join

  • Current psychotic symptoms or perceptual problems.
  • The presence of a contraindication to PTX, such as a drug allergy or xanthine derivative allergy.
  • Patients with substance dependence or abuse.
  • Patients with concurrent active medical condition (congestive heart failure, abnormal electrocardiogram, malignancy, schizophrenia, neurological disease).
  • Patients with inflammatory disorders and/or auto-immune conditions (rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, lupus)

Trial locations and contacts

1 site in 1 country.

Iraq1 site

  • Hawler Psychiatric Hospital and Private Clinic

    Erbil, 44001

Other trials in Iraq

About this study

Official title: Pentoxifylline for Treatment of Resistant Major Depression: A Randomized, Double Blind, Placebo Controlled Trial

A growing body of evidence has highlighted the role of inflammation and phosphodiesterases (PDE)-related pathways in the pathogenesis of neuropsychiatric illnesses such as depression/mood disorders. Herein, we aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in the treatment of therapy-resistant depression (TRD) in adult patients with bipolar depression.

Read the detailed description

Depression, which affects an estimated 300 million people worldwide, is the main cause of mental health-related illness burden. Depression keeps people from attaining their full potential, depletes human capital, and is linked to suicide and other forms of mortality. Despite the fact that depressive disorders have a better prognosis than primary psychotic illnesses like schizophrenia, 20%-40% of patients treated with antidepressants do not respond to their initial treatment regimens, and up to 15% do not respond to multiple antidepressant regimens and modalities, such as electroconvulsive shock (ECT) therapy. Since the treatment resistance has been shown to increase the likelihood of full symptomatic recurrence, worsen the treatment course and quality of life; therefore, there is a critical need for innovative treatment techniques for patients who have failed to respond to traditional treatments. Inflammation is one factor that has gotten a lot of attention lately as an etiologic mechanism of treatment-resistant depression (TRD). Increased levels of (pro) inflammatory markers such as tumor necrosis factor-alpha (TNF-α), interleukin (IL)-1, and IL-6 are reported in a considerable percentage of patients with major depressive disorders with or without other comorbidities, including bipolar depression and TRD patients. Also, clinical factors connected to antidepressant response are linked to the reduction of inflammatory cytokines.

Moreover, cytokine antagonists, such as the chimeric anti-TNF-alpha antibody infliximab, has shown antidepressant efficacy. Hence, given the elevated levels of inflammatory activity in TRD patients, new treatments with anti-inflammatory effect might be an effective approach to treat these patients. Pentoxifylline (PTX) is a methylated xanthine derivative that has been used to treat peripheral vascular disease for more than two decades. PTX has anti-inflammatory and phosphodiesterase (PDE) inhibitory effects that enables it to inhibit PDEs competitively. Subsequently, it can increase cAMP levels, activate protein kinase A (PKA), inhibit ILs and TNF-α production, and reduce inflammation. Therefore, PTX-decreased inflammatory activity, may give rapid symptomatic alleviation for medically healthy individuals with TRD depression.

Being tested
Pentoxifylline, Placebo
Keywords
Bipolar Depression, Pentoxifylline, Resistant Major Depression
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PentoxifyllineDrug

    Also called Trental

    All participants will receive pentoxifylline 400 mg (orally ingested) twice a day for 12 weeks.

  • PlaceboDrug

    Also called Sugar Pills

    All participants will receive placebo (orally ingested) twice a day for 12 weeks.

Study groups in NCT05324735
Study groupRoleWhat they receive
PentoxifyllineExperimentalPentoxifylline (tablet): 400 mg twice a day for 12 weeks
Receives: Drug: Pentoxifylline
Control groupPlacebo comparatorPlacebo (tablet): twice a day for 12 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Depression Rating Scale-17 (HAM-D-17) Scores

    The HAM-D-17 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 HAM-D-17 total score ≤ 7 (primary outcome).

    Measured: 12 weeks

Secondary outcomes (5)

  1. Response Rate

    The number of patients with a ≥ 50% drop in the Hamilton Depression Rating Scale-17 (HAM-D-17) total score.

    Measured: 12 weeks

  2. Remission Rate

    The number of patients reaching depression remission. Remission is defined as Hamilton Depression Rating Scale-17 (HAM-D-17) total score ≤ 7.

    Measured: 12 weeks

  3. Serum level of CRP

    Peripheral blood samples will be collected to assess changes in the serum levels of C- reactive protein (mg/dl).

    Measured: 12 weeks

  4. Serum level of TNF-α

    Peripheral blood samples will be collected to assess changes in the serum levels of tumor necrosis factor alpha (pg/ml).

    Measured: 12 weeks

  5. Serum level of IL-6

    Peripheral blood samples will be collected to assess changes in the serum levels of Interleukin-6 (pg/ml).

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start15 Dec 2021
  3. Primary completion4 May 2022
  4. Study completion4 Jun 2022

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05324735
Sponsor's protocol ID
HMU PE-EC 24112021/391
Status last verified
Sep 2022
First submitted
25 Mar 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pentoxifylline in people with Resistant Major Depression, 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 5 inclusion and 5 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 (HAM-D-17) Scores (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05324735.

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.

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