307
Participants
Start Date
March 22, 2018
Primary Completion Date
October 31, 2021
Study Completion Date
November 30, 2021
CBT-I plus placebo
Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus placebo (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days)
CBT-I plus Melatonin 3 mg
Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 3 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days.
CBT-I plus Melatonin 5 mg
Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 5 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days.
RECRUITING
CEDOES - Centro de Diagnóstico e Pesquisa da Osteoporose do Espirito Santo., Vitória
TERMINATED
Hospital de Clínicas de Porto Alegre, Porto Alegre
RECRUITING
Allergisa Pesquisa Dermato Cosmética Ltda., Campinas
TERMINATED
Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC, Santo André
RECRUITING
Centro de Desenvolvimento em Estudo Clínicos Brasil - CDEC Brasil, São Paulo
RECRUITING
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto USP, Ribeirão Preto
RECRUITING
Dr Consulta Clinica Medica Ltda, São Paulo
TERMINATED
Centro Paulista de Investigação Clínica e Serviços Médicos Ltda., São Paulo
Lead Sponsor
Ache Laboratorios Farmaceuticos S.A.
INDUSTRY