A Randomized Clinical Trial for Depressed Mothers at Primary Care Level (DMH)
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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 |
- 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 ]
| 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 |
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| Chile | |
| CORESAM Conchali | |
| Santiago, Region Metropolitana, Chile | |
| 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 May 19, 2013