ReclutandoNCT07065240Registro de ClinicalTrials.gov

A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)

Major Depressive Disorder (MDD) · Major Depressive Disorder With Anxious Distress

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - 65 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 360 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Participant is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent.
Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline.
Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.
Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP agree to use an acceptable form of highly effective contraception during participation in the study and for 30 days after receiving the last dose of study treatment.
Body mass index (BMI) between 18 to 40 kg/m2, inclusive.
Participant is willing and able to refrain from the use of drugs of abuse.

Exclusion Criteria:

History of, or current presentation consistent with:

1. any depressive episode with psychotic or catatonic features.
2. any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode.
3. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.
4. schizophrenia, schizoaffective, or other psychotic disorder.
5. obsessive-compulsive disorder.
6. any persistent neurocognitive disorder.
* History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode.
* Psychiatric hospitalization within current depressive episode.
* Evidence or history of clinically significant diseases which can affect the patients' participation.
* Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300/placebo formulation.
* Participant has a history of drug or alcohol use disorder.
* Participants with a positive test for cannabinoids.
* Clinically significant risk of suicide or harm to self or others.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento cuádruple

SPT-300

Participants will receive SPT-300 capsules once daily for 42 days

Drug: SPT-300

Placebo

Participants will receive matching placebo once daily for 42 days

Drug: Placebo

SPT-300 DRUG

A prodrug of allopregnanolone, a small molecule drug

Placebo DRUG

Placebo for SPT-300

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score

Plazo: Baseline (Day 0) to Day 42

HAM-D-17 is a 17-item, clinician-administered rating scale to assess the severity of symptoms in participants diagnosed with depression. The HAM-D-17 comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. HAM-D Total Scores range from 0 to 52, with higher scores indicating more severe depression.

Medidas secundarias

Change From Baseline to Day 42 in Clinical Global Impression - Severity (CGI-S)

Plazo: Baseline (Day 0) to Day 42

The CGI-S is a clinician-administered rating scale to assess the severity of the participant's illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. Scores range from 1 to 7, with higher scores indicating more severe illness.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (62)

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Buscar un centro en este estudio

62 centros

Seaport Investigator SiteChino, California, United StatesReclutando

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (62)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research