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New drug SP-624 targets brain waves in depression study

NCT ID NCT06570369

Knowledge-focused Sponsor: Sirtsei Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 trial tested whether the experimental drug SP-624 affects brain electrical activity in 26 people — some healthy, some with major depression. Participants took SP-624 or a placebo daily for two weeks. Researchers used EEG and AI to look for changes in brain networks, and also checked memory and learning in those with depression. The main goal was to see if SP-624 has any measurable effect on the brain, not yet to treat the condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SP-624
What this could lead to
If this early study shows SP-624 changes brain activity in a helpful way, it could point toward a new treatment for depression.
What could go wrong
This is a very small, early Phase 1 trial focused on measuring brain signals, not treating depression. It may show no meaningful effect, and results may not lead to a real treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

26 people

The number who actually took part.

Started

Aug 2024

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * In generally good health * Body mass index (BMI) between 18.0 and 40.0 kg/m2 * Willing to comply with the requirements of the study * For participants with depression: must meet study criteria for moderate to severe major depressive disorder Key Exclusion Criteria: * Female who is pregnant or breastfeeding. * Clinically significant health condition or clinically significant abnormal results on screening health tests * For participants with depression: presence of exclusionary study criteria for co-morbid psychiatric conditions or medication history.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Healthy Major depressive disorder

Contacts and locations

Locations

  • Alivation Research

    Lincoln, Nebraska, 68526, United States

  • CenExel CNS

    Garden Grove, California, 92845, United States

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