Deprexis for Depression
(Deprexis Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Must be taking: Psychotropic medications
Disqualifiers: Psychotic disorder, Bipolar I, suicidal risk
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Eligibility 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
+1 more
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
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: DeprexisExperimental Treatment1 Intervention
Deprexis: an internet-delivered psychosocial treatment for depressive symptoms and related functional impairment.
Group II: Treatment-as-UsualActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TXWaco, TX
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Monoamine oxidase inhibitors as anti-depressant drugs and as adjunct to L-dopa therapy of Parkinson's disease. [2019]Monoamine oxidase inhibitors have been used in psychiatric disorders for many years. However, due to the toxic side effects of the drugs they are often replaced by the tri- and tetracyclic antidepressants. Selective monoamine oxidase inhibitors like deprenyl, however, have been tried with success as adjuvant therapy in Parkinson's disease and depression because of their ability to inhibit dopamine oxidation. Perhaps their greatest advantage is their lack of pressor response.
Deprenyl in Parkinson disease. [2019](-)Deprenyl, a specific monoamine oxidase subtype B inhibitor (MAOI-B), has been reported to be a safe and valuable adjunct to conventional treatment of parkinsonism. A double-blind, clinical comparison of (-)deprenyl with placebo was undertaken in 11 parkinsonian patients; the efficacy of 10 mg daily was studied over 4 weeks. In four cases the clinical score for parkinsonian deficits improved during deprenyl therapy, and in five it deteriorated; there was no change in one patient. Two subjects failed to complete the study. (-)Deprenyl induced euphoria and insomnia. It was concluded that any advantages deriving from the use of (-)deprenyl in parkinsonism are limited, and probably dominated by its elevation of mood. Biochemical analysis failed to reveal any significant increase in platelet or plasma catecholamine concentrations during deprenyl therapy. There was, however, a significant decrease in plasma epinephrine (p
A controlled study of the antidepressant efficacy and side effects of (-)-deprenyl. A selective monoamine oxidase inhibitor. [2019]Monoamine oxidase (MAO) inhibitors are effective antidepressants whose use is limited because of unwanted side effects and the possibility of a tyramine-induced hypertensive crisis (cheese reaction). (-)-Deprenyl (the official nonproprietary name for this substance is selegiline), a selective MAO type B inhibitor, may be safer and have fewer side effects, but its antidepressant efficacy is uncertain. A double-blind placebo-controlled study was carried out in depressed outpatients who were treated with (-)-deprenyl in an MAO type B selective dose range and at a higher nonselective dose range. (-)-Deprenyl did not have a statistically significant antidepressant effect after three weeks of treatment at doses of 10 mg/d. However, after six weeks and at higher doses (averaging about 30 mg/d for the second three weeks), (-)-deprenyl was superior to placebo in antidepressant effect with a positive response rate of 50% vs 13.6% and with a 41% reduction in the Hamilton Depression Rating Scale mean score vs 10% in the placebo-treated group. No hypertensive crises were seen. The rate of occurrence of side effects with (-)-deprenyl was no greater than with placebo. It was concluded that (-)-deprenyl is an effective antidepressant in a dose range where it is distinguished by the absence of many of the side effects typical of nonselective MAO inhibitors.
L-Deprenyl does not reduce brain damage in global forebrain ischemia in adult gerbils (Meriones ungiculatus). [2019]Delayed neuronal death is produced at about the 4th day following global forebrain ischemia. This study investigates whether L-deprenyl, an irreversible and selective MAO-B inhibitor, reduces brain damage following global forebrain ischemia in adult gerbils. For this purpose, global forebrain ischemia was induced in adult gerbils by occlusion for 5 min of both common carotid arteries. L-Deprenyl, 10 mg/kg weight in saline (10 mg/ml) i.p., was administered 1 h after or 2 h before occlusion, followed by daily administration for 4 days. Treated animals were processed in parallel with ischemic animals receiving saline alone, and with sham-operated controls. Counts of viable neurons were made in the pyramidal cell layer of the CA1 region of the hippocampus at the 4th day after the ischemic episode. The number of viable neurons in the pyramidal cell layer of CA1 was similar in animals treated with L-deprenyl or saline alone (Mann-Whitney U-test, alpha=0.05 two-tailed). The present results show that L-deprenyl does not prevent neuronal cell death following global forebrain ischemia in the adult gerbil when the administration of the drug is started shortly after or shortly before the ischemic episode.
Experiences with L-deprenyl in Parkinsonism. [2019]In about 2/3 of the cases studied (152 patients), the combination of deprenyl and the substitution-therapy has a favourable effect as it tends to normalize motor activity. Although the administering of deprenyl renders neither L-Dopa nor the decarboxylase inhibitor superfluous, their side effects can be slightly reduced as their dose is reduced. Therefore it is advised to give all patients a trial with this drug.