A Randomized Clinical Trial for Depressed Mothers at Primary Care Level (DMH)
|ClinicalTrials.gov Identifier: NCT00519051|
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : August 21, 2007
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.
|Condition or disease||Intervention/treatment|
|Depression||Other: monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||345 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official 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|
|Study Start Date :||March 2004|
|Study Completion Date :||December 2006|
Active Comparator: control group
patients can receive pharmacotherapy and psychotherapy and specialized treatment
Other: monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)
Fluoxetine oral,20-60 mg/day for 6 months with telephone monitorization
Other Name: usual care
- depressive symptoms measured with the HDRS [ Time Frame: at 3,6 and 12 months after randomization ]
- quality of life measured with the SF-36 [ Time Frame: at 3,6 and 12 months after randomization ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519051
|Santiago, Region Metropolitana, Chile|
|Principal Investigator:||rosemarie fritsch, MD||University of Chile|