Depressive DisordersPhase 3NCT00010517
Acupuncture in the Treatment of Depression
A Phase 3 study testing Acupuncture in people with Depressive Disorders and Depression, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The current large randomized placebo-controlled trial is testing the ability of acupuncture to treat major depression. The study is unique in that treatment effects will be from the perspective of both Western psychiatry and Chinese medicine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depressive Disorders, Depression
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Apr 2002
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must meet criteria for Major Depression.
- Must be free of other mental or physical disorders that could cause depression, and also free from conditions that would typically exclude participants from trials involving pharmacologic antidepressants.
- Cannot be receiving other treatments or require immediate clinical attention.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The current large randomized placebo-controlled trial is testing the ability of acupuncture to treat major depression. The study is unique in that treatment effects will be from the perspective of both Western psychiatry and Chinese medicine.
Read the detailed description
Depression is an unfortunately common condition for which people often seek alternative (non-Western) treatments, perhaps because conventional treatments do not consistently provide lasting relief. A pilot study (Allen, Schnyer and Hitt, 1998) suggests that acupuncture, a popular but under-researched alternative treatment derived from Chinese medicine, holds sufficient promise as a treatment for depression to warrant a larger-scale clinical trial. The investigators propose to conduct a larger-scale test of the efficacy of acupuncture in this trial. Because relapse and recurrence of Major Depression are quite common, the investigators also will assess the clinical status of participants for 18 months after treatment concludes. In the first phase of this double-blind randomized clinical trial, 150 men and women meeting criteria for Major Depression will be randomly assigned to a treatment approach or to a waitlist control. All participants will ultimately receive acupuncture designed to address their own particular constellation of depressive symptoms. At the end of this first phase, blind assessments will be used to compare treatment effects from the perspectives of both Western psychiatry and Chinese medicine. After this treatment phase, participants will be assessed several times over the next 18 months. The study is designed to evaluate the efficacy and clinical significance of acupuncture as a treatment for Major Depression, and to examine the convergence of Western-based and Chinese-medicine-based outcome measures. Finally, the study will determine whether changes in energetic pattern mediate changes in Western defined depression severity, and explore whether patient and history variables predict responses to acupuncture treatments.
- Conditions
- Depressive Disorders, Depression
- Being tested
- Acupuncture
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2001 (estimated)
- Study startSep 1997
- Study completionApr 2002
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 Depressive DisordersStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- John J. Allen, PhD, Principal investigator, University of Arizona, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010517
- Sponsor's protocol ID
- R01 AT000001-01M
- Other IDs
- R01AT000001-01
- Status last verified
- Mar 2008
- First submitted
- 2 Feb 2001
- Last updated
- 7 Mar 2008
- Results posted
- No
Publications
Allen JJ, Schnyer RN, Chambers AS, Hitt SK, Moreno FA, Manber R. Acupuncture for depression: a randomized controlled trial. J Clin Psychiatry. 2006 Nov;67(11):1665-73. doi: 10.4088/jcp.v67n1101.
PubMed 17196044
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in the Treatment of Depression
- ClinicalTrials.gov ID
- NCT00010517
- Acronym / sponsor ID
- R01 AT000001-01M
- Conditions
- Depressive Disorders, Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 1997
- Study completion
- Apr 2002
- First posted
- 5 Feb 2001 (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.
The current large randomized placebo-controlled trial is testing the ability of acupuncture to treat major depression. The study is unique in that treatment effects will be from the perspective of both Western psychiatry and Chinese medicine.
Detailed description
Depression is an unfortunately common condition for which people often seek alternative (non-Western) treatments, perhaps because conventional treatments do not consistently provide lasting relief. A pilot study (Allen, Schnyer and Hitt, 1998) suggests that acupuncture, a popular but under-researched alternative treatment derived from Chinese medicine, holds sufficient promise as a treatment for depression to warrant a larger-scale clinical trial. The investigators propose to conduct a larger-scale test of the efficacy of acupuncture in this trial. Because relapse and recurrence of Major Depression are quite common, the investigators also will assess the clinical status of participants for 18 months after treatment concludes. In the first phase of this double-blind randomized clinical trial, 150 men and women meeting criteria for Major Depression will be randomly assigned to a treatment approach or to a waitlist control. All participants will ultimately receive acupuncture designed to address their own particular constellation of depressive symptoms. At the end of this first phase, blind assessments will be used to compare treatment effects from the perspectives of both Western psychiatry and Chinese medicine. After this treatment phase, participants will be assessed several times over the next 18 months. The study is designed to evaluate the efficacy and clinical significance of acupuncture as a treatment for Major Depression, and to examine the convergence of Western-based and Chinese-medicine-based outcome measures. Finally, the study will determine whether changes in energetic pattern mediate changes in Western defined depression severity, and explore whether patient and history variables predict responses to acupuncture treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must meet criteria for Major Depression.
- Must be free of other mental or physical disorders that could cause depression, and also free from conditions that would typically exclude participants from trials involving pharmacologic antidepressants.
- Cannot be receiving other treatments or require immediate clinical attention.
Key exclusion criteria (0 listed)
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 | – |
Primary outcome
Not reported in the source record.
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 7 Mar 2008.
- Derived from this study: PubMed 17196044Allen JJ, Schnyer RN, Chambers AS, Hitt SK, Moreno FA, Manber R. Acupuncture for depression: a randomized controlled trial. J Clin Psychiatry. 2006 Nov;67(11):1665-73. doi: 10.4088/jcp.v67n1101.
Related trials for Depressive Disorders
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
John J. Allen, PhD principal investigator
University of Arizona, Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture in people with Depressive Disorders and Depression, run by National Center for Complementary and Integrative Health (NCCIH) 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?
The sponsor lists 3 inclusion and 0 exclusion criteria. 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 7 Mar 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00010517, 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 7 Mar 2008.