NCT04388202 (LEAP-SE) is a Phase 4 clinical trial of Sertraline in Major Depressive Disorder, sponsored by Alto Neuroscience.

Who is sponsoring NCT04388202?

NCT04388202 is sponsored by Alto Neuroscience.

What drugs are being tested in NCT04388202?

Interventions in NCT04388202: Sertraline, Escitalopram.

What condition does NCT04388202 study?

NCT04388202 studies Major Depressive Disorder.

Is NCT04388202 still recruiting?

NCT04388202 is currently withdrawn. Last updated 19 October 2020.

Last reviewed 2020-10-19 · How we verify

NCT04388202: LEAP-SE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram

Withdrawn Phase 4 Last updated 19 October 2020

What this trial tests

Phase 4 trial testing Sertraline in Major Depressive Disorder. Withdrawn.

Timeline

15 October 2020

Primary endpoint
30 May 2023

30 May 2023

Quick facts

Lead sponsor	Alto Neuroscience
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	15 October 2020
Primary completion	30 May 2023
Estimated completion	30 May 2023

Drugs / interventions tested

Sertraline (sertraline) — full drug profile →
Escitalopram (escitalopram) — full drug profile →

Conditions studied

Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Alto Neuroscience — full company profile →

Who can join

Adults 22 to 85, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The LEAP-SE study will be conducted to validate the utility of EEG biomarkers as an aid to antidepressant treatment selection in adults with MDD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Sertraline

Trials testing the same drug.

NCT06408246 — ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression · Phase 2 · recruiting
NCT05603104 — Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First- · Phase 3 · recruiting
NCT06827431 — The Research of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression · Phase 3 · not yet recruiting
NCT05973786 — The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in · Phase 3 · recruiting
NCT05892744 — Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression · Phase 4 · recruiting

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting

Other Alto Neuroscience trials

Trials by the same sponsor.

NCT06391593 — PD, PK, and Safety of ALTO-203 in Patients With MDD · Phase 2 · completed
NCT05712187 — Phase 2b Study of ALTO-100 in MDD · Phase 2 · completed
NCT05419869 — Pilot Decentralized Trial · Phase 2 · completed
NCT05157945 — ALTO-300 in Depression (ALTO-300-004) · Phase 2 · completed
NCT05117632 — ALTO-100 in MDD and/or PTSD · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04388202 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alto Neuroscience
Last refreshed: 19 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04388202.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing