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Completed

NCT Number: NCT00519051

A Randomized Clinical Trial for Depressed Mothers at Primary Care Level

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CORESAM Conchali

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)

Other

Fluoxetine oral,20-60 mg/day for 6 months with telephone monitorization

Other names: usual care

Primary outcomes

  1. depressive symptoms measured with the HDRS

    Time frame: at 3,6 and 12 months after randomization

Secondary outcomes

  1. quality of life measured with the SF-36

    Time frame: at 3,6 and 12 months after randomization

Sponsors and collaborators

Lead sponsor

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Other Gov

Registry information

Official study 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

Acronym: DMH

Important dates

Study start
2004
Study completion
2006
First posted
Aug 21, 2007
Registry last updated
Aug 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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