NCT00519051

A Randomized Clinical Trial for Depressed Mothers at Primary Care Level

Efectividad de la Farmacoterapia Monitorizada en Pacientes Deprimidas de la atención Primaria de Salud y su repercusión Sobre la Salud Mental de Sus Hijos

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized clinical trial was carried out at primary care level in Santiago, Chile to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (TM) and the usual treatment (TH) and its impact on children's mental health. Hypothesis: pharmacological intervention for depression controlled by phone from a central level will be more effective than usual care in depressed mothers.

Detailed description

Aim:to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (TM) and the usual treatment (TH) and its impact on children's mental health. Material and methods: A RCT wasw carried out at primary care clinics in Santiago.Sample:three hundred and forty five depressed women . One children of each mother was randomly selected. Women are randomly assigned to receive the usual therapy or a pharmacological intervention with periodical telephone contacts with medical collaboration personnel, to reinforce compliance with treatment and educate about the disease, for 6 months. Women were blindly evaluated at 3, 6 and 12 months with the Hamilton depression rating score (HDRS) and the SF-36 to assess depressive symptoms and quality of life, respectively; the Dyadic Adjustment Scale to assess marital adjustment. Child psychopathology was assessed with the Child Behavior Checklist (CBCL), the Brief Psychiatric Rating Scale for Children (BPRS-C), Screen for Child Anxiety Related Emotional Disorders(SCARED)and the Children's Depression Inventory.

Conditions

• Depression

Interventions

Type	Name	Description
OTHER	monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)	Fluoxetine oral,20-60 mg/day for 6 months with telephone monitorization

Timeline

• Start date: 2004-03-01
• Completion: 2006-12-01
• First posted: 2007-08-21
• Last updated: 2007-08-21

Locations

1 site across 1 country: Chile