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A Randomized Clinical Trial for Depressed Mothers at Primary Care Level

NCT ID: NCT00519051

Last Updated: 2007-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

patients can receive pharmacotherapy and psychotherapy and specialized treatment

Group Type ACTIVE_COMPARATOR

monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)

Intervention Type OTHER

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

Interventions

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monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)

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

Intervention Type OTHER

Other Intervention Names

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usual care

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

OTHER_GOV

Sponsor Role lead

Principal Investigators

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rosemarie fritsch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

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CORESAM Conchali

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

References

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Fritsch R, Araya R, Solis 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. Spanish.

Reference Type RESULT
PMID: 17657327 (View on PubMed)

Other Identifiers

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1040432

Identifier Type: -

Identifier Source: org_study_id