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Depression drug trial halted early – what happened?

NCT ID NCT06618118

Symptom relief Sponsor: AbbVie 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 study tested a new medicine called fosigotifator for adults with major depressive disorder. The goal was to see if it is safe and helps with depression symptoms. About 20 people were enrolled before the study was stopped early. Participants took either the drug or a placebo, and researchers checked for side effects and mood changes.

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

20 people

The number who actually took part.

Started

Oct 2024

Finished

Sep 2025

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

20 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: * Body mass index of 18 to 33 kg/m2 at the time of consent. * Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for MDD based on the Structured Clinical Interview for DSM-5. * Current major depressive episode of at least 6 weeks to less than 24 months in duration at Screening (Visit 1 ). * Meets the following disease activity criteria mentioned in the protocol. * Requires antidepressant therapy (ADT) per the investigator's opinion or, if currently taking ADT, must be able to safely discontinue ADT at least 7 days prior to the first dose of study drug at Baseline (Visit 2). Exclusion Criteria: \- Primary psychiatric illness other than MDD.

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

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

Major depressive disorder (MDD)

Contacts and locations

Locations

  • CenExel CNR /ID# 265866

    Sherman Oaks, California, 91403, United States

  • CenExel iResearch, LLC /ID# 265886

    Decatur, Georgia, 30030-3440, United States

  • Clinical Neuroscience Solutions - Orlando - East South Street /ID# 265060

    Orlando, Florida, 32801, United States

  • Northwest Clinical Research Center /ID# 265057

    Bellevue, Washington, 98007, United States

More trials for these conditions

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