NCT00186654

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_2 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

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 25, 2008

Status Verified

August 1, 2008

First QC Date

September 14, 2005

Last Update Submit

September 22, 2008

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Depression severity and response status after 8 weeks of treatment

Secondary Outcomes (1)

  • Depression severity at 3, 6, & 9 months post partum; delivery outcome

Interventions

AcupuncturePROCEDURE
Perinatal massagePROCEDURE

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 20177281DERIVED

MeSH Terms

Conditions

Depression

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Rachel Manber

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Last Updated

September 25, 2008

Record last verified: 2008-08

Locations

US(1)