Skip to content

A Randomized Clinical Trial for Depressed Mothers at Primary Care Level

Efectividad de la Farmacoterapia Monitorizada en Pacientes Deprimidas de la atención Primaria de Salud y su repercusión Sobre la Salud Mental de Sus Hijos

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00519051
Acronym
DMH
Enrollment
345
Registered
2007-08-21
Start date
2004-03-31
Completion date
2006-12-31
Last updated
2007-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

depression, primary care, pharmacotherapy

Brief summary

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.

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.

Interventions

OTHERmonitorized pharmacotherapy with antidepressants drugs (Fluoxetine)

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

Sponsors

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
depressive symptoms measured with the HDRSat 3,6 and 12 months after randomization

Secondary

MeasureTime frame
quality of life measured with the SF-36at 3,6 and 12 months after randomization

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026