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ENX-104 MAD Study for Participants With Major Depressive Disorder With Anhedonia (aMDD)

NCT ID: NCT07253324

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-17

Study Completion Date

2025-11-26

Brief Summary

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The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ENX-104 in participants with major depressive disorder with anhedonia (aMDD).

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ENX-104

Group Type EXPERIMENTAL

ENX-104

Intervention Type DRUG

Oral Solution

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution

Interventions

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ENX-104

Oral Solution

Intervention Type DRUG

Placebo

Oral solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Biologically female participants (defined as assigned female at birth)

1. Of non-childbearing potential, defined as either permanently sterilized or postmenopausal and with a negative pregnancy test.
2. Of childbearing potential and willing to use both a highly effective method of contraception and a condom with any partner or remain abstinent, and with a negative pregnancy test
3. Not currently breastfeeding or lactating, and not intending to initiate breastfeeding during the course of study conduct
* Biologically male participants (defined as assigned male at birth), if fertile must be willing to have a partner use a highly effective method of contraception and participant use a condom with any partner of childbearing potential, or remain abstinent

Exclusion Criteria

* Unable or unwilling to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, should not participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Engrail Therapeutics INC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MAC Clinical Research

Blackpool, Lancashire, United Kingdom

Site Status

MAC Clinical Research

Prescot, Merseyside, United Kingdom

Site Status

MAC Clinical Research

Cannock, South Staffordshire, United Kingdom

Site Status

MAC Clinical Research

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ENX-104-003

Identifier Type: -

Identifier Source: org_study_id