A Prospective, Double Blind, Randomized, Multicenter Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform the Prescription of Medications to Patients With a Primary Diagnosis of a Depressive Disorder Versus Treatment as Usual.
PEER Interactive Report
Trastornos Relacionados con el Estrés y el Trauma+1
+ Trastornos Mentales
+ Trastorno depresivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 2013
Fecha en la que se inscribió al primer participante.This study is prospective in nature. Subjects in the control group will be treated according to treatment as usual and best judgment of the treating physician. For the experimental group the treating physician will follow the guidance of the subject's PEER Interactive Report as regards sensitivity to on-label medications and classes of medication. The subjects will be washed out of all current medications prior to having an EEG, which is necessary to generate the PEER Interactive Report. The wash out period for outpatients is no longer than 14 days. The subjects will be followed for 6 months after the initial treatment, or until the patient has achieved maximum medical improvement (MMI). The patient will be seen on a routine basis and assessments will be made at each interaction to evaluate the patient's improvement in mental health. The subjects will also be closely evaluated to determine if they are experiencing any psychiatric specific adverse events. The investigator is allowed to treat the patient according to their best medical judgment, which may include adding or changing medications, seeing the patient more frequently, or other interventions such as the use of sleep aids.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 1922 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Must speak and read English Must be able to provide written informed consent A primary diagnosis of a DSM-IV depressive disorder Co-morbidities of non-psychotic behavioral disorders, including PTSD and mild Traumatic Brain Injury (mTBI) are eligible to participate. Able to stop all medications (wash out) for 5 half-lves of all medication(s) which affect the EEG. Outpatient subjects are eligible if they can be washed out of their medications in 14 days or less. Ability to comply with the requirements of the study Exclusion Criteria: Diagnosis of a psychotic disorder History of, or current, open head trauma Subjects who would not be good candidates to be washed out of their medications, in the opinion of the investigator. History of craniotomy, cerebral metastases, cerebrovascular accident, current diagnosis of seizure disorder, bipolar disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features, or use of depot neuroleptics in the last 12 months. Clinically significant medical illness, including thyroid disorders. Participation in any other therapeutic drug study within 60 days preceding inclusion in the study. Know pregnancy and/or lactation, or intent to become pregnant during the study. Chronic or acute pain requiring prescription medication(s). Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG Candidates that are currently stable and considered to be at maximum medical improvement on current medications.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Sin IntervenciónObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
Walter Reed National Military Medical Center
Bethesda, United StatesAbrir Walter Reed National Military Medical Center en Google MapsFort Belvoir Community Hospital
Fort Belvoir, United States