NCT00519051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
Last Updated

August 21, 2007

Status Verified

August 1, 2007

First QC Date

August 17, 2007

Last Update Submit

August 20, 2007

Conditions

Depression

Keywords

depressionprimary carepharmacotherapy

Outcome Measures

Primary Outcomes (1)

  • depressive symptoms measured with the HDRS

    at 3,6 and 12 months after randomization

Secondary Outcomes (1)

  • quality of life measured with the SF-36

    at 3,6 and 12 months after randomization

Study Arms (1)

control group

ACTIVE COMPARATOR

patients can receive pharmacotherapy and psychotherapy and specialized treatment

Other: monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)

Interventions

monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)OTHER

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

Also known as: usual care
control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • depressed mothers with al least one child aged 6-16

You may not qualify if:

  • currently treatment for depression,psychosis,bipolar depression,alcohol or drug abuse, gravidity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CORESAM Conchali

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (1)

  • 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.

    PMID: 17657327RESULT

MeSH Terms

Conditions

Depression

Interventions

Antidepressive AgentsFluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Psychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesPropylaminesAminesOrganic Chemicals

Study Officials

  • rosemarie fritsch, MD

    University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 17, 2007

First Posted

August 21, 2007

Study Start

March 1, 2004

Study Completion

December 1, 2006

Last Updated

August 21, 2007

Record last verified: 2007-08

Locations

CL(1)