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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Deprexis, an online tool designed to reduce depressive symptoms and improve daily functioning in Veterans. The goal is to determine if Deprexis is effective and user-friendly for Veterans with mild to moderate depression. Participants will be divided into two groups: one using Deprexis and the other receiving regular care, to compare outcomes. Veterans with internet access and stable mild or moderate depression are well-suited for this trial. As an unphased trial, this study provides Veterans the opportunity to contribute to research that could enhance mental health care options.

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.

What prior data suggests that Deprexis is safe for Veterans?

A previous study found Deprexis to be safe and effective for treating depression in non-hospitalized individuals. Participants experienced symptom improvements without major safety concerns. Another study showed that users of Deprexis had fewer depression symptoms over 8 to 12 weeks. This evidence suggests that Deprexis can be a helpful and safe option for managing depression symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for depression, which often involve medication or face-to-face therapy sessions, Deprexis is unique because it is an internet-delivered psychosocial treatment. This innovative approach allows individuals to access therapy online, making it more convenient and accessible, especially for those who may have difficulty attending in-person sessions. Researchers are excited about Deprexis because it could offer a flexible, scalable option that fits into people's busy lives while still effectively addressing depressive symptoms and related functional impairments.

What evidence suggests that Deprexis might be an effective treatment for depression?

Research has shown that Deprexis, an online self-help program, can effectively reduce symptoms of depression. In this trial, some participants will receive Deprexis as an internet-delivered psychosocial treatment. Studies have found that people using Deprexis felt much better after 8 to 12 weeks. Specifically, one study found that Deprexis helped reduce depression in a wide range of people. This online program also improved social skills, helping people feel more connected and involved with others. Overall, Deprexis appears to be a promising tool for managing depression. ^{3 6 7 8 9}

Who Is on the Research Team?

Rahel R Pearson, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37590052/

Effectiveness of an Internet-Based Self-Guided Program to ... Conclusions: These results replicate previous findings by showing that Deprexis can facilitate symptomatic improvement over 3 months in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6992171/

Effectiveness of a tailored, integrative Internet intervention ... These findings demonstrate that deprexis can facilitate clinically relevant reduction of depressive symptoms over 8–12 weeks across a broad range of initial ...

3. researchprotocols.org researchprotocols.org/2024/1/e59119

The Evaluation of a Web-Based Intervention (Deprexis) to ... A randomized controlled trial (RCT) of Deprexis in a general population sample found that it was effective in reducing depressive symptoms, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214782914000402

Effects of an Internet intervention (Deprexis) on severe ... This randomized controlled trial aimed to examine the effect of an Internet intervention that was deployed without personal support (“Deprexis”) among adults

5. jmir.org jmir.org/2009/2/e15/

Effectiveness of a Novel Integrative Online Treatment for ... Conclusions: This integrative, Web-based intervention was effective in reducing symptoms of depression and in improving social functioning.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32874927/

Feasibility, effectiveness and safety of the self ... Taken together, these data show that deprexis can be used effectively and safely in the routine care of depressed outpatients.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7450999/

Feasibility, effectiveness and safety of the self-management ... It found that the usage intensity of deprexis was adequate and associated with improvement in range of outcomes: a decrease in both clinician- and self-rated ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0228100

Effectiveness of a tailored, integrative Internet intervention ... These findings demonstrate that deprexis can facilitate clinically relevant reduction of depressive symptoms over 8–12 weeks across a broad range of initial ...

9. us.deprexis.com us.deprexis.com/

deprexis® | Digital Therapy for Depression | Homepage deprexis is clinically proven to significantly reduce depressive symptoms. deprexis® is a 12-week online program that can help people create more positive ...