A Randomized Clinical Trial for Depressed Mothers at Primary Care Level

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00519051
• Date of registration: 17/08/2007
• Prospective Registration: No
• Primary sponsor: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
• Public title: A Randomized Clinical Trial for Depressed Mothers at Primary Care Level DMH
• Scientific title: Efectividad de la Farmacoterapia Monitorizada en Pacientes Deprimidas de la atención Primaria de Salud y su repercusión Sobre la Salud Mental de Sus Hijos
• Date of first enrolment: March 2004
• Target sample size: 345
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00519051
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Chile

Contacts

• Name: rosemarie fritsch, MD
• Affiliation: University of Chile

Key inclusion & exclusion criteria

Inclusion Criteria:

- depressed mothers with al least one child aged 6-16

Exclusion Criteria:

- currently treatment for depression,psychosis,bipolar depression,alcohol or drug
abuse, gravidity.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Other: monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)

Primary Outcome(s)

depressive symptoms measured with the HDRS [Time Frame: at 3,6 and 12 months after randomization]

Secondary Outcome(s)

quality of life measured with the SF-36 [Time Frame: at 3,6 and 12 months after randomization]

Secondary ID(s)

1040432

Source(s) of Monetary Support

Please refer to primary and secondary sponsors