Acupuncture and Massage for Depression During Pregnancy | NCT00186654

Studies
Acupuncture and Massage for Depression During Pregnancy

NCT00186654

Sponsor

Stanford University

Status

Completed

Last Update Posted

Sep 25, 2008Estimated

Enrollment

180

Phase

Phase 2

Conditions

Depression

Interventions

Acupuncture
Perinatal massage

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

Status Module

Record Verification Date

Aug 2008

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 16, 2005Estimated

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 22, 2008

Last Update Posted Date

Sep 25, 2008Estimated

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED

Description Module

Brief Summary

This study evaluates the efficacy of acupuncture and massage for the treatment of depression during pregnancy. The study also examines differential effects of study treatments on delivery outcome and post partum depression.

Detailed Description

Participants in this study are randomly assigned to one of the three experimental groups that include two types of acupuncture treatment and perinatal massage. The two acupuncture treatments are delivered in a double-blind fashion. Treatments consist of an acute phase during which participants receive 12 treatment sessions over a period of 8 weeks. Responders and partial responders enter a continuation phase during which they receive weekly treatments that end 10 weeks post delivery. At the end of the continuation phase, participants continue to be clinically assessed at 3 and 6 months after the end of treatment to detail the natural course of relapse to the index episode in the three treatment groups.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180

Measure	Description	Time Frame
Depression severity and response status after 8 weeks of treatment

Measure	Description	Time Frame
Depression severity at 3, 6, & 9 months post partum; delivery outcome

Eligibility Module

Eligibility Criteria

Inclusion Criteria:- Meet criteria for a current major depressive episode with an HRSD(17) score of at least 14.

Ambulatory women (age³18) with a viable pregnancy,
Pregnancy between 22 and 30 weeks of gestation
Fluent in English

Exclusion Criteria:- Meeting criteria for a primary Axis I disorder in past 2 months, other than unipolar depression or social phobia

Seasonal affective disorder or episode duration of 2 years or more (chronic depression)
Abnormal results on a laboratory screen that will include a thyroid panel and a drug screen.
Serious uncontrolled medical conditions or conditions that may be a medical basis of a depression.
Cluster B personality disorders.
Confounding treatments for depression, including any psychotherapy, herbs, or pharmacotherapy.
Current use of any prescribed psychotropic medication or any medication that impacts mood.
Treatment with ECT or vagal nerve stimulation during the last year.
Current active suicidal potential necessitating immediate treatment.
Absence of prenatal care from an OBGYN practitioner in the community.
Any condition that necessitates bed rest.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel Manber	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20177281	Derived	Manber R, Schnyer RN, Lyell D, Chambers AS, Caughey AB, Druzin M, Carlyle E, Celio C, Gress JL, Huang MI, Kalista T, Martin-Okada R, Allen JJB. Acupuncture for depression during pregnancy: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):511-520. doi: 10.1097/AOG.0b013e3181cc0816.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure
Perinatal massage	Procedure