DepressionPhase 2NCT00186654
Acupuncture and Massage for Depression During Pregnancy
A Phase 2 study testing Acupuncture and Perinatal massage in people with Depression, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Acupuncture and Perinatal massage
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Acupuncture, Perinatal massage
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Perinatal massageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity and response status after 8 weeks of treatment
Secondary outcomes (1)
Depression severity at 3, 6, & 9 months post partum; delivery outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Rachel Manber, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186654
- Sponsor's protocol ID
- HS09988
- Status last verified
- Aug 2008
- First submitted
- 14 Sep 2005
- Last updated
- 25 Sep 2008
- Results posted
- No
Publications
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.
PubMed 20177281
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Massage for Depression During Pregnancy
- ClinicalTrials.gov ID
- NCT00186654
- Acronym / sponsor ID
- HS09988
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
| Perinatal massage | Procedure or surgery | – |
Primary outcome
Depression severity and response status after 8 weeks of treatment
1 secondary outcome
Depression severity at 3, 6, & 9 months post partum; delivery outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2008.
- Derived from this study: PubMed 20177281Manber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Manber principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture and Perinatal massage in people with Depression, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity and response status after 8 weeks of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00186654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2008.