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Study on the Effectiveness and Safety of Ulotaront for Adults with Generalized Anxiety Disorder

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Ulotaront on adults with Generalized Anxiety Disorder (GAD). Generalized Anxiety Disorder is a condition characterized by excessive and persistent worry about various aspects of life. The medication being tested, Ulotaront, is taken in the form of a tablet and is also known by its code name SEP-363856. The study will compare the effects of Ulotaront with a placebo to determine its effectiveness and safety in treating GAD.

The purpose of the study is to evaluate how well Ulotaront works in reducing anxiety symptoms in adults with GAD. Participants in the study will receive either Ulotaront or a placebo, and the doses of Ulotaront will range from 50 to 75 milligrams per day. The study will be conducted over a period of time, allowing researchers to observe changes in anxiety levels and any potential side effects. The study aims to provide valuable information on the potential benefits of Ulotaront for individuals with Generalized Anxiety Disorder.

Throughout the study, participants will be monitored to assess changes in their anxiety symptoms using a tool called the Hamilton Anxiety Rating Scale. This scale helps measure the severity of anxiety symptoms. The study will also look at overall impressions of the participants' condition using another tool called the Clinical Global Impression-Severity score. By the end of the study, researchers hope to gather important data on the effectiveness and safety of Ulotaront in treating Generalized Anxiety Disorder.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as age and diagnosis of generalized anxiety disorder.

    You will be asked to provide consent to participate and will receive detailed information about the study procedures and schedule.

  2. Step 2

    Baseline assessment

    A baseline assessment will be conducted to evaluate your current condition. This includes measuring your anxiety levels using the Hamilton Anxiety Rating Scale (HAM-A).

    This assessment will help establish a starting point for evaluating changes throughout the study.

  3. Step 3

    Randomization and medication

    You will be randomly assigned to receive either the study medication, ulotaront, or a placebo. The medication will be in the form of a tablet taken orally.

    The dosage will be flexible, ranging from 50 to 75 mg per day, and will be adjusted based on your response and tolerance.

  4. Step 4

    Treatment period

    During the treatment period, you will take the assigned medication daily. Regular visits will be scheduled to monitor your progress and any side effects.

    Your anxiety levels will be assessed periodically using the HAM-A and other scales to track changes from the baseline.

  5. Step 5

    Final assessment

    At the end of the study, a final assessment will be conducted to evaluate the overall changes in your condition.

    The results will be compared to the baseline to determine the effectiveness of the treatment.

Who can join the trial?

4 criteria

  • Must be a male or female between 18 to 65 years old.
  • Must have a diagnosis of Generalized Anxiety Disorder (GAD) according to the DSM-5 criteria. (DSM-5 is a manual used by healthcare professionals to diagnose mental disorders.)
  • Must be willing and able to follow the study procedures and visit schedule.
  • Must be able to understand and follow verbal and written instructions.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with generalised anxiety disorder cannot participate.
  • Patients who are not within the age range specified for the study cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

SEP-363856 is a medication being studied for its potential to help people with generalized anxiety disorder, which is a condition that causes excessive and persistent worry. This medication is being tested to see if it can reduce anxiety symptoms and improve the overall well-being of those who take it. The study aims to determine how effective and safe this medication is for treating anxiety by comparing it to a placebo, which is a substance with no active ingredients. Participants in the trial receive different doses of SEP-363856 to find the most effective amount for reducing anxiety symptoms.

What is already known about the treatment

SEP-363856 – SEP-363856 is administered orally in the form of flexible-dose tablets, typically ranging from 50 to 75 mg per day. It is currently being studied in clinical trials for its effectiveness and safety in treating generalized anxiety disorder (GAD). The main therapeutic indication for SEP-363856 is to alleviate symptoms of anxiety in adults diagnosed with GAD. At the molecular level, SEP-363856 works by modulating neurotransmitter systems in the brain, which helps to reduce anxiety symptoms. It is classified pharmacologically as an antipsychotic, although its exact mechanism in treating anxiety is still under investigation.

Investigated diseases

Generalized Anxiety Disorder – Generalized Anxiety Disorder is a mental health condition characterized by persistent and excessive worry about various aspects of life, such as work, health, or social interactions. This worry is difficult to control and often occurs more days than not for at least six months. Individuals with this disorder may experience restlessness, fatigue, difficulty concentrating, irritability, muscle tension, and sleep disturbances. The anxiety and worry are not confined to specific situations or objects, making it a pervasive condition. Over time, the symptoms can interfere with daily activities and relationships. The disorder tends to be chronic, with symptoms fluctuating in intensity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-502077-42-00Protocol codeSEP361-226Estimated enrolment434 patientsSponsorOtsuka Pharmaceutical Development & Commercialization Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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