Deprexis for Depression

(Deprexis Trial)

Overseen By Joseph F Maher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Psychotropic medications

Disqualifiers: Psychotic disorder, Bipolar I, suicidal risk

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

152 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should be stable on psychotropic medications. This suggests you may continue your current medications if they are stable.

How does the drug Deprexis differ from other treatments for depression?

Deprexis, also known as deprenyl or selegiline, is unique because it is a selective monoamine oxidase type B inhibitor (MAO-B inhibitor), which means it targets a specific enzyme involved in breaking down mood-related chemicals in the brain. Unlike other MAO inhibitors, it has fewer side effects and does not cause a hypertensive crisis (dangerously high blood pressure) when consuming certain foods. ^{1 2 3 4 5}

What is the purpose of this trial?

Depressive symptoms are common among Veterans and associated with significant impairment. Timely intervention has the potential to improve mental health outcomes and restore functioning. Interventions delivered through the internet can be completed remotely at any time, and thus minimize burden on Veterans, however the research examining their utility in Veterans is limited. This proposed project will examine Deprexis, a self-guided internet-delivered intervention, which targets depressive symptoms and associated functional impairments. Interviews will be conducted to gain insight into Veterans' perceptions, needs, and preferences vis-a-vis Deprexis, with results informing a randomized controlled trial. Here an 8-week course of Deprexis will be compared to a treatment-as-usual (TAU) control condition to establish if Deprexis is acceptable and effective for Veterans with mild to moderate depressive symptoms. Veterans engaged in Deprexis are hypothesized to show improvements on measures of functioning and decreases in depressive symptoms compared to the TAU control group. The proposed work has great clinical utility, as it could provide a readily accessible, high-quality intervention for the many Veterans suffering from depressive symptoms, with the potential to improve functioning and long-term outcomes.

Research Team

Rahel R Pearson, PhD

Principal Investigator

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Eligibility Criteria

This trial is for Veterans experiencing mild to moderate depression. Participants should be interested in a self-guided, internet-based intervention and available for an 8-week course. Specific eligibility criteria are not provided, but typically participants would need access to the internet and have no conditions that significantly interfere with study participation.

Inclusion Criteria

I am a Veteran with mild or moderate depression.

Potential participants include male and female Veterans of all races/ethnicities who are able to comprehend and sign the informed consent form

Potential participants include male and female Veterans of all races/ethnicities who have reliable access to the internet and a computer, tablet and/or smartphone

Exclusion Criteria

Aim 1 and Aim 2: Veterans will be excluded from study participation if they report current suicidal risk

Aim 1 and Aim 2: Veterans will be excluded from study participation if they endorse any positive symptoms of a psychotic disorder

Aim 1 and Aim 2: Veterans will be excluded from study participation if they screen positive for Bipolar I Disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week course of Deprexis, a self-guided internet-delivered intervention, compared to a treatment-as-usual control condition

8 weeks

Remote access, self-guided

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, post-treatment, and 8-week follow-up

8 weeks

Remote assessments

Treatment Details

Interventions

• Deprexis

Trial Overview The trial tests Deprexis, an online program designed to help manage depressive symptoms. Veterans will either use Deprexis or receive their usual treatment over eight weeks. The goal is to see if Deprexis can improve mental health outcomes and daily functioning more than standard treatments.

Participant Groups

Group I: Deprexis Experimental Treatment 1 Intervention

Deprexis: an internet-delivered psychosocial treatment for depressive symptoms and related functional impairment.

Group II: Treatment-as-Usual Active Control 1 Intervention

Access to standard non-study care

Deprexis is already approved in United States for the following indications:

Approved in United States as Deprexis for:

• Mild to moderate depressive symptoms

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Selective monoamine oxidase inhibitors, such as deprenyl, have shown promise as adjuvant therapy in treating Parkinson's disease and depression due to their ability to inhibit dopamine oxidation.

Unlike traditional monoamine oxidase inhibitors, selective ones like deprenyl have a significant advantage of not causing a pressor response, making them safer for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monoamine oxidase inhibitors as anti-depressant drugs and as adjunct to L-dopa therapy of Parkinson's disease. Youdim, MB.[2019]

In a study of 11 parkinsonian patients over 4 weeks, (-)deprenyl showed mixed results, with some patients experiencing improvement in parkinsonian symptoms while others deteriorated, indicating limited overall efficacy.

The treatment was associated with side effects like euphoria and insomnia, and while it decreased plasma epinephrine and platelet MAO activity, it did not significantly increase catecholamine levels, suggesting its effects may be more related to mood elevation than direct improvement in parkinsonism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deprenyl in Parkinson disease. Eisler, T., Teräväinen, H., Nelson, R., et al.[2019]

In a double-blind placebo-controlled study, (-)-deprenyl (selegiline) showed significant antidepressant effects after six weeks at higher doses (around 30 mg/d), with a positive response rate of 50% compared to 13.6% for placebo.

The study found that (-)-deprenyl did not cause hypertensive crises and had a side effect profile similar to that of placebo, indicating it may be a safer alternative to traditional MAO inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled study of the antidepressant efficacy and side effects of (-)-deprenyl. A selective monoamine oxidase inhibitor. Mann, JJ., Aarons, SF., Wilner, PJ., et al.[2019]

In a study involving adult gerbils, L-deprenyl, an irreversible MAO-B inhibitor, was administered before and after a 5-minute global forebrain ischemia, but it did not reduce brain damage or prevent neuronal cell death in the CA1 region of the hippocampus.

The results indicate that L-deprenyl is ineffective in protecting neurons from ischemic damage when given shortly before or after the ischemic event, suggesting that timing of administration is crucial for potential neuroprotective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

L-Deprenyl does not reduce brain damage in global forebrain ischemia in adult gerbils (Meriones ungiculatus). Ballabriga, J., Pellisé, A., Ferrer, I.[2019]

In a study of 152 patients, the combination of deprenyl with substitution therapy improved motor activity in about two-thirds of the cases, indicating its potential efficacy in treatment.

While deprenyl does not replace the need for L-Dopa or decarboxylase inhibitors, it can help reduce their side effects by allowing for lower doses, suggesting a safer treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences with L-deprenyl in Parkinsonism. Csanda, E., Antal, J., Antóny, M., et al.[2019]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Monoamine oxidase inhibitors as anti-depressant drugs and as adjunct to L-dopa therapy of Parkinson's disease. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Deprenyl in Parkinson disease. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A controlled study of the antidepressant efficacy and side effects of (-)-deprenyl. A selective monoamine oxidase inhibitor. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

L-Deprenyl does not reduce brain damage in global forebrain ischemia in adult gerbils (Meriones ungiculatus). [2019]

5. Austria pubmed.ncbi.nlm.nih.gov

Experiences with L-deprenyl in Parkinsonism. [2019]