- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01418638
The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder
Objective There is growing evidence showing a relation between depression, metabolic syndrome, diabetes, cardiovascular disease (1), serum lipid profile (2,3) and body weight (4), as well as the effects of some of the antidepressant medications on these various conditions and profiles.
The aim of the study is to examine the influence of antidepressant medications on the metabolic profiles (5) of patients suffering from Major Depressive Disorder (MDD).
Group of patients:
30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.
Research Design and Methods:
Research duration will be 8 weeks. Patients meeting the inclusion criteria will be recruited after being diagnosed with MDD and having undertaken the HDRS. A follow-up HDRS will be taken at weeks 4 and 8. The psychiatric evaluation will be held by a resident in psychiatry.
The following metabolic parameters will be examined at base-line and at the end of the 8 weeks:
Weight, height, waist circumference, body mass index (BMI: (Weight in Kg/(Height in meters)2), sitting blood pressure (after 3 minutes of sitting).
Serum lipid profile (performed in Ziv hospital's chemistry lab): Low density lipoprotein cholesterol, High density Lipoprotein cholesterol, Triglycerides, Total cholesterol, Apolipoprotein level (Apo AI, Apo B, Apo E, Apo AII).
Fasting glucose and insulin blood levels, in order to evaluate insulin-release and resistance, according to the following formulas:
Insulin Resistance:
HOMA IR=Fasting glucose (mg/dL)x Fasting insulin (mmol/L)/405
Insulin Release:
HOMA-β={360xfasting insulin (mmol/L)}/{glucose(mg/dL)-63} Serum oxidative stress parameters according to the F2-Isoprostane kit will be measured.
Malonylaialdehyde (MDA) content in serum will be analyzed by the thiobarbituric acid reactive substances assay, which measures malondialdehyde equivalent (13). Conjugated dienes will be measured at 234nm (14, 15).
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Osamah Hussein, MD
- Correo electrónico: osama.h@ziv.health.gov.il
Ubicaciones de estudio
-
-
-
Safed, Israel, 13110
- Reclutamiento
- Ziv MC
-
Investigador principal:
- Osamah Hussein, MD
-
Contacto:
- Osamah Hussein, MD
-
-
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
Inclusion Criteria:
- MDD diagnosed patients with a Hamilton Depression Rating Scale (HDRS) score of at least 18 points. Patients not treated with medications or such that had shown resistance to treatment, and were therefore assigned for drug replacement.
- Patients on stable therapy for hypertension, diabetes mellitus, hypothyroidism, dyslipidemia and / or weight lowering medications
Exclusion Criteria:
- Patients receiving antipsychotic treatment as well as patients on mood stabilizers will be excluded.
- Patients with uncontrolled diabetes mellitus, uncontrolled thyroid functioning, or uncontrolled hypertension, as well as patients who regularly consume alcohol will be excluded.
- Patients with uncontrolled malignancy are excluded as well.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
30 Patients with MDD.
30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
the influence of antidepressant medications on the metabolic profiles (5) of patients suffering from Major Depressive Disorder.
Periodo de tiempo: 8 WEEKS
|
8 WEEKS
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Osamah Hussein, MD, Ziv Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 01-11 ZIV
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. .