Expired Study
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Stanford, California 94305


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

HS09988


NCT ID:

NCT00186654


Secondary ID:


Study Acronym:


Brief Title:

Acupuncture and Massage for Depression During Pregnancy


Official Title:

Acupuncture and Massage for Depression During Pregnancy


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

180


Enrollment Type:


Overall Contact Information

Official Name:Rachel Manber
Principal Investigator
Stanford University

Study Dates

Verification Date:August 2008
Last Changed Date:September 22, 2008
First Received Date:September 14, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Depression severity at 3, 6, & 9 months post partum; delivery outcome
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Depression severity and response status after 8 weeks of treatment
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Acupuncture
Intervention Type:Procedure
Name:Perinatal massage

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Agency for Healthcare Research and Quality (AHRQ)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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