Clinician Managed Interpersonal Psychotherapy | NCT00043602

Studies
Clinician Managed Interpersonal Psychotherapy

NCT00043602

Sponsor

University of Iowa

Status

Completed

Last Update Posted

Sep 26, 2013Estimated

Enrollment

140Actual

Phase

Early Phase 1

Conditions

Depression
Depression, Postpartum

Interventions

Standard interpersonal psychotherapy (IPT)
Clinician managed interpersonal psychotherapy (CM-IPT)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH059668	U.S. NIH Grant/Contract		View source
DSIR 83-ATAS

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2001

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Aug 9, 2002

First Submission Date that Met QC Criteria

Aug 12, 2002

First Posted Date

Aug 13, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2013

Last Update Posted Date

Sep 26, 2013Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Standard interpersonal psychotherapy (IPT)	Behavioral	Participants will receive 12 sessions of IPT over 12 weeks.	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hamilton Rating Scale for Depression		Measured at Week 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott P. Stuart, MD	University of Iowa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Iowa		Iowa City	Iowa	52242	United States

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D019052	Depression, Postpartum

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D011644	Puerperal Disorders
D011248	Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided