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NCT06618118 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess Adverse Events of Fosigotifator (ABBV-CLS-7262) in Adults With Major Depressive Disorder

A Phase 1 study, sponsored by AbbVie.

Terminated
Registry status
Phase 1
Development phase
20
Enrollment target

NCT06618118 is a Phase 1 study that was terminated before completion, run by AbbVie. The registered enrollment target is 20 participants.

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The verdict

NCT06618118, a Phase 1 study, was terminated before completion, sponsored by AbbVie.

TERMINATED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tiredness, changes in eating habits, and aches and pains. The main goal of the study is to evaluate how safe and effective fosigotifator is in treating MDD. Fosigotifator (ABBV-CLS-7262) is a new treatment being developed for adult patients with depression. This study is double-blinded, which means that neither the patients nor the study doctors know who is given fosigotifator and who is given placebo. Participants will be randomly assigned to one of the two groups to receive fosigatofator or placebo. There is 1 in 2 chance that participants will receive placebo. Approximately 106 adult participants with MDD will be enrolled in approximately 15 sites across the world. Participants will receive oral fosigotifator or matching placebo. Duration of the study is approximately 144 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Interventions

  • DRUG Placebo
  • DRUG Fosigotifator

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-10-23
Est. Completion 2025-09-23
Phase Phase 1

Sponsor

AbbVie

526 total trials

What the Registry Record Tells You About NCT06618118

The ClinicalTrials.gov registry entry for NCT06618118 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT06618118 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT06618118 about?

NCT06618118 is a clinical study titled "A Study to Assess Adverse Events of Fosigotifator (ABBV-CLS-7262) in Adults With Major Depressive Disorder". Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tir...

What is the current status of trial NCT06618118?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-10-23. Estimated completion is 2025-09-23.

What interventions are being tested in trial NCT06618118?

The interventions under investigation include: Placebo (DRUG), Fosigotifator (DRUG).

Who is sponsoring clinical trial NCT06618118?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.