Postnatal DepressionDPPNCT00518830
Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile
A study testing multi-component intervention in people with Postnatal Depression, run by Fondo Nacional de Desarrollo Científico y Tecnológico, Chile.
Trial summary
A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- multi-component intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mothers meeting criteria for current DSM-IV major depression were eligible.
Who cannot join
- who had received any form of treatment for their depression during their current postnatal period,
- those who were pregnant,
- with psychotic symptoms,
- serious suicidal risk,
- history of mania,
- alcohol or drug abuse
About this study
Official title: Randomized Clinical Trial for the Treatment of Postnatal Depression
A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development.
Read the detailed description
Background: We compared the effectiveness of a multi-component intervention with usual care to treat postnatal depression among low-income mothers in primary care clinics in Santiago, Chile.
Methods: Randomised controlled trial. Two hundred and thirty mothers with major depression attending postnatal clinics were randomly allocated to either a multi-component intervention or usual care. The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed. Data were analysed on an intention-to-treat basis. The main outcome measure was the Edinburgh Postnatal Depression Scale (EPDS) at 3 and 6 months after randomisation.
- Conditions
- Postnatal Depression
- Being tested
- multi-component intervention, Usual care
- Keywords
- postnatal depression, primary care, depressed women
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-component interventionOther
The PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance
Usual careOther
included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
| Study group | Role | What they receive |
|---|---|---|
| PND-MCI | Experimental | The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed Receives: Other: multi-component intervention |
| usual care | Active comparator | 'Usual care' included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPDS
Measured: 3 and 6 months
Secondary outcomes (1)
four dimensions of the Short Form-36 (SF-36) Questionnaire: mental health; emotional role; social functioning; and vitality(34) and significant clinical improvement.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startMar 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Sponsor type
- Other government
- Investigators
- Graciela Rojas, MD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518830
- Sponsor's protocol ID
- 1040434
- Acronym
- DPP
- Status last verified
- Jul 2007
- First submitted
- 20 Aug 2007
- Last updated
- 21 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Rojas G, Fritsch R, Solis J, Jadresic E, Castillo C, Gonzalez M, Guajardo V, Lewis G, Peters TJ, Araya R. Treatment of postnatal depression in low-income mothers in primary-care clinics in Santiago, Chile: a randomised controlled trial. Lancet. 2007 Nov 10;370(9599):1629-37. doi: 10.1016/S0140-6736(07)61685-7.
PubMed 17993363
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for the Treatment of Postnatal Depression
- ClinicalTrials.gov ID
- NCT00518830
- Acronym / sponsor ID
- DPP / 1040434
- Conditions
- Postnatal Depression
- Keywords
- postnatal depression, primary care, depressed women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Fondo Nacional de Desarrollo Científico y Tecnológico, ChileOther government
- Study start
- Mar 2004
- Study completion
- Jul 2006 (actual)
- First posted
- 21 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development.
Detailed description
Background: We compared the effectiveness of a multi-component intervention with usual care to treat postnatal depression among low-income mothers in primary care clinics in Santiago, Chile.
Methods: Randomised controlled trial. Two hundred and thirty mothers with major depression attending postnatal clinics were randomly allocated to either a multi-component intervention or usual care. The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed. Data were analysed on an intention-to-treat basis. The main outcome measure was the Edinburgh Postnatal Depression Scale (EPDS) at 3 and 6 months after randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PND-MCI | Experimental | Other: multi-component interventionThe multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed |
| usual care | Active comparator | Other: Usual care'Usual care' included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers meeting criteria for current DSM-IV major depression were eligible.
Key exclusion criteria (6 listed)
- who had received any form of treatment for their depression during their current postnatal period,
- those who were pregnant,
- with psychotic symptoms,
- serious suicidal risk,
- history of mania,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-component interventionThe PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance | Other | PND-MCI |
| Usual careincluded all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment | Other | usual care |
Primary outcome
EPDS
Time frame: 3 and 6 months
1 secondary outcome
four dimensions of the Short Form-36 (SF-36) Questionnaire: mental health; emotional role; social functioning; and vitality(34) and significant clinical improvement.
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2007.
- Derived from this study: PubMed 17993363Rojas G, Fritsch R, Solis J, Jadresic E, Castillo C, Gonzalez M, Guajardo V, Lewis G, Peters TJ, Araya R. Treatment of postnatal depression in low-income mothers in primary-care clinics in Santiago, Chile: a randomised controlled trial. Lancet. 2007 Nov 10;370(9599):1629-37. doi: 10.1016/S0140-6736(07)61685-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graciela Rojas, MD principal investigator
University of Chile
Questions about this trial
What is this clinical trial studying?
A study testing multi-component intervention in people with Postnatal Depression, run by Fondo Nacional de Desarrollo Científico y Tecnológico, Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EPDS (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2007.