NCT00043602

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for early_phase_1 depression

Timeline
Completed

Started Sep 2001

Longer than P75 for early_phase_1 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2002

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

6.3 years

First QC Date

August 9, 2002

Last Update Submit

September 25, 2013

Conditions

DepressionDepression, Postpartum

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression

    Measured at Week 12

Study Arms (2)

1

EXPERIMENTAL

Participants will receive clinician-managed interpersonal psychotherapy

Behavioral: Clinician managed interpersonal psychotherapy (CM-IPT)

2

ACTIVE COMPARATOR

Participants will receive standard interpersonal psychotherapy

Behavioral: Standard interpersonal psychotherapy (IPT)

Interventions

Standard interpersonal psychotherapy (IPT)BEHAVIORAL

Participants will receive 12 sessions of IPT over 12 weeks.

2
Clinician managed interpersonal psychotherapy (CM-IPT)BEHAVIORAL

Participants will receive 12 sessions of CM-IPT over 1 year.

1

Eligibility Criteria

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

You may qualify if:

  • Women between 8 and 24 weeks postpartum
  • Meet DSM-IV criteria for Major Depression
  • Hamilton Rating Scale for Depression score of 12 or more

You may not qualify if:

  • Active substance abuse
  • Psychotic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

DepressionDepression, Postpartum

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Scott P. Stuart, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2002

First Posted

August 13, 2002

Study Start

September 1, 2001

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations

US(1)