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IMPase in Treatment-resistant Depression

NCT05117710 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-06

No results posted yet for this study

Summary

This experimental medicine study will examine the effects of a brief period (seven days) of 'add on' ebselen (SPI-105) treatment in patients with resistant depression to see if ebselen produces changes in emotional responses consistent with a potential clinical antidepressant effect. The investigators will also seek to confirm ebselen's mode of action on IMPase by measuring changes in a brain chemical called inositol, using a magnetic imaging method. Half of the participants will receive ebselen and the other half placebo.

Conditions

  • Depressive Disorder, Treatment-Resistant

Interventions

DRUG

Ebselen

Ebselen is an organoselenium compound, developed originally as an antioxidant for use in neuroprotection, post-stroke. Ebselen is a bioavailable and brain penetrant inhibitor of inositol monophosphatase (IMPase) (Ki ≈ 1 μM).

DRUG

Placebo

Matched placebo capsules

Sponsors & Collaborators

  • Medical Research Council

    collaborator OTHER_GOV

  • Sound Pharmaceuticals, Incorporated

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Philip J Cowen, MBBS, MD · Dept. Psychiatry, University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05117710 on ClinicalTrials.gov