A Randomized Clinical Trial for Depressed Mothers at Primary Care Level (DMH)
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|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||Phase|
|Depression||Other: monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)||Not Applicable|
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|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|