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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02798094
Stress Sensitivity and Reward Responsivity in Depression (CAN-BIND-04)
Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major Depression
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Participants will participate in two 3-hour sessions separated by a week at Providence Care, Mental Health Services, and a third, 1.5-hour session at the Queen's MRI Facility. At the first session participants will complete a packet of questionnaires about their mood and take part in an interview about their mood, medications, drug use, and any other symptoms, as well as an interview about their relationships with their parents and any experiences of abuse. At the second session participants will participate in a stress test, which involves giving a speech to a panel. The investigators will also collect saliva samples to look at stress hormones. Participants will also complete a task on the computer that involves looking at cartoon faces and making decisions about them. At the third session, the investigators take images of of participant's brain using a magnetic resonance scanner.
Participants are invited to participate in a 6-month follow-up for this study, which would involve the same procedure as outline above.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Kingston, Ontario, Canadá, K7L 3N6
- Queen's University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
For Depressed Participants:
Inclusion Criteria:
- Outpatients aged 18-65
- Currently suffering from unipolar depression
- Fluency in English, sufficient to complete the interviews and self-report questionnaires
Exclusion Criteria:
- Clinical diagnosis of bipolar disorder, psychotic disorders, current alcohol/substance dependence, or significant medical comorbidity
- Treatment-resistant (defined as failing more than 3 trials of anti-depressant medication)
- History of neurological insult (e.g., concussion), neurological disease, seizure disorder
- Smokers
- Pregnant women
- Endocrine disorders
- High suicidal risk, defined by clinician judgement
For Healthy Control Participants:
Inclusion Criteria:
- Adults aged 18-65
- No history of Axis I disorders according to DSM-IV-TR criteria, as determined by the SCID
- No first-degree relatives diagnosed with bipolar disorder
- Fluency in English, sufficient to complete the interviews and self-report questionnaires
Exclusion Criteria:
- History of neurological insult (e.g., concussion), neurological disease, seizure disorder
- Smokers
- Pregnant women
- Endocrine disorders
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Depressed Participants
No intervention
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Healthy Control Participants
No intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Stress Sensitivity: Salivary Hormone and Stress Challenge Test (TSST)
Periodo de tiempo: 2 hours after beginning of Time B Appointment
|
Participants are required to give a speech and an arithmetic test in front of a panel.
Saliva samples are collected at 8 points throughout the test.
|
2 hours after beginning of Time B Appointment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mood and Anxiety Symptom Questionnaire (MASQ)
Periodo de tiempo: Administered at first baseline appointment and covers past 2 weeks
|
Self-report scale of general distress (GD), anhedonic depression (AD), and anxious arousal (AA) symptoms
|
Administered at first baseline appointment and covers past 2 weeks
|
Reward Responsivity: Probabilistic Reward Task
Periodo de tiempo: Administered at second baseline appointment
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Computerized task that requires participants to choose between two stimuli and develop a response bias to the more frequently rewarded stimulus.
|
Administered at second baseline appointment
|
Snaith Hamilton Pleasure Scale (SHAPS and SHAPS-C)
Periodo de tiempo: Administered at first baseline appointment and covers past 2 weeks prior to interview
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Self-report of anhedonia symptoms
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Administered at first baseline appointment and covers past 2 weeks prior to interview
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kate Harkness, PhD, Queens University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PSYC-154-14
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .