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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00043602
Other study ID # R01MH059668
Secondary ID R01MH059668DSIR
Status Completed
Phase Phase 0
First received August 9, 2002
Last updated September 25, 2013
Start date September 2001
Est. completion date December 2007

Study information

Verified date September 2013
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard IPT.


Description:

CM-IPT is delivered in 12 sessions over the course of a year. Standard IPT is delivered in 12 sessions in the first 12 weeks after treatment assignment.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria:

- Women between 8 and 24 weeks postpartum

- Meet DSM-IV criteria for Major Depression

- Hamilton Rating Scale for Depression score of 12 or more

Exclusion criteria:

- Active substance abuse

- Psychotic disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard interpersonal psychotherapy (IPT)
Participants will receive 12 sessions of IPT over 12 weeks.
Clinician managed interpersonal psychotherapy (CM-IPT)
Participants will receive 12 sessions of CM-IPT over 1 year.

Locations

Country Name City State
United States University of Iowa Iowa City Iowa

Sponsors (2)

Lead Sponsor Collaborator
University of Iowa National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Rating Scale for Depression Measured at Week 12 No
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