A Randomized Clinical Trial for Depressed Mothers at Primary Care Level

Depression Clinical Trial

— DMH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519051
• Other study ID #: 1040432
• Status: Completed
• Phase: N/A
• First received: August 17, 2007
• Last updated: August 20, 2007
• Start date: March 2004
• Est. completion date: December 2006

Study information

• Verified date: August 2007
• Source: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression

Intervention

Other:
• monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)
Fluoxetine oral,20-60 mg/day for 6 months with telephone monitorization

Locations

Country	Name	City	State
Chile	CORESAM Conchali	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Fritsch R, Araya R, Solís J, Montt E, Pilowsky D, Rojas G. [A randomized trial of pharmacotherapy with telephone monitoring to improve treatment of depression in primary care in Santiago, Chile]. Rev Med Chil. 2007 May;135(5):587-95. Epub 2007 Jul 9. Span — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depressive symptoms measured with the HDRS		at 3,6 and 12 months after randomization
Secondary	quality of life measured with the SF-36		at 3,6 and 12 months after randomization