A Randomized Clinical Trial for Depressed Mothers at Primary Care Level (DMH)

This study has been completed.
Sponsor:
Information provided by:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
ClinicalTrials.gov Identifier:
NCT00519051
First received: August 17, 2007
Last updated: August 20, 2007
Last verified: August 2007
  Purpose

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 Intervention
Depression
Other: monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fondo Nacional de Desarrollo Científico y Tecnológico, Chile:

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

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

Enrollment: 345
Study Start Date: March 2004
Study Completion Date: December 2006
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519051

Locations
Chile
CORESAM Conchali
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Investigators
Principal Investigator: rosemarie fritsch, MD University of Chile
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00519051     History of Changes
Other Study ID Numbers: 1040432
Study First Received: August 17, 2007
Last Updated: August 20, 2007
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by Fondo Nacional de Desarrollo Científico y Tecnológico, Chile:
depression
primary care
pharmacotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Fluoxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on April 17, 2014