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SPL026 With or Without SSRIs in Participants With MDD

NCT05553691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-06-14

No results posted yet for this study

Summary

The main aim of the study is to test the safety and tolerability of single doses of SPL026 (N,N-dimethyltryptamine \[DMT\] fumarate, a psychedelic tryptamine) in patients currently taking a selective serotonin reuptake inhibitor (SSRI) for their depression, but for whom the SSRI is not fully relieving their depression.

Conditions

Interventions

DRUG

SPL026

Intravenous

Sponsors & Collaborators

  • Small Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Fabian Devlin, MD · MAC Clinical Research

  • Neel Bhatt, MD · MAC Clinical Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-13
Primary Completion
2023-08-03
Completion
2023-08-03

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

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 NCT05553691 on ClinicalTrials.gov