Generalized Anxiety DisorderPhase 4NCT00120458
Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety
A Phase 4 study testing Black cohosh in people with Generalized Anxiety Disorder and Menopause, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will determine the effectiveness of the herb black cohosh for treating menopause-related anxiety symptoms in women. Study hypotheses: 1) Black cohosh will have a superior anti-anxiety effect compared to placebo. 2) Black cohosh will have a comparable safety profile to that of placebo. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Generalized Anxiety Disorder, Menopause
- What is being tested?
- Black cohosh
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2008
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently experiencing menopause or postmenopausal
- Have symptoms of menopause-related anxiety
Who cannot join
- Any form of generalized anxiety disorder (GAD) unrelated to menopause
- Onset of GAD at least 3 years prior to menopause or at least 5 years after menstruation has stopped
- Alcohol or drug dependence within 3 months prior to study entry
- Allergy to black cohosh
- History of hormone replacement therapy
- Current use of vaginal estrogen cream or phytoestrogens
Show all 14Show fewer
- Current use of tranquilizers, antidepressants, or antianxiety therapies
- Abnormal uterine bleeding
- History of estrogen-dependent cancer
- History of endometrial hyperplasia (abnormal increase in cells) or endometrial cancer
- Rapidly growing uterine fibroids
- Abnormal finding upon gynecological examination that would interfere with the study
- Abnormal breast examination or mammogram
- Any unstable medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Research Unit, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104-3309
About this study
Official title: Black Cohosh Therapy for Menopause-Related Anxiety
This study will determine the effectiveness of the herb black cohosh for treating menopause-related anxiety symptoms in women.
Study hypotheses: 1) Black cohosh will have a superior anti-anxiety effect compared to placebo. 2) Black cohosh will have a comparable safety profile to that of placebo.
Read the detailed description
During menopause, up to 90% of women will experience symptoms of anxiety, such as nervousness, irritability, fatigue, muscle aches, depression, and low libido. Concern over the safety and effectiveness of hormone replacement therapy for relieving these symptoms has caused many women to seek alternative medical treatments. Data suggest that black cohosh has a direct effect on the neurotransmitters and receptors involved in anxiety. This study will determine whether black cohosh can effectively treat anxiety symptoms in menopausal women.
This study will last 12 weeks. Participants will be randomly assigned to receive either black cohosh or placebo daily for the duration of the study. Self-report scales will be used to assess participants' anxiety symptoms and quality of life at the beginning and end of the study.
- Conditions
- Generalized Anxiety Disorder, Menopause
- Being tested
- Black cohosh
- Keywords
- Black Cohosh, Cimicifuga, Anxiety, Women, Complementary and Alternative Medicine
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black cohoshDietary supplement
32 to 128 mg (black cohosh)
1 to 4 capsules daily (placebo)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Anxiolytic Therapy Receives: Dietary Supplement: Black cohosh |
| 2 | Placebo comparator | Anxiolytic Therapy Receives: Dietary Supplement: Black cohosh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Hamilton Anxiety Rating Scale
Measured: 12 Weeks
Secondary outcomes (1)
Quality of life and functional outcome ratings
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2008
- Study completionDec 2008
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 Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Investigators
- Jay D. Amsterdam, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120458
- Sponsor's protocol ID
- R21AT002289-01A1
- Other IDs
- R21AT002289-01A1
- Status last verified
- Mar 2010
- First submitted
- 14 Jul 2005
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amsterdam JD, Yao Y, Mao JJ, Soeller I, Rockwell K, Shults J. Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause. J Clin Psychopharmacol. 2009 Oct;29(5):478-83. doi: 10.1097/JCP.0b013e3181b2abf2.
PubMed 19745648
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Black Cohosh Therapy for Menopause-Related Anxiety
- ClinicalTrials.gov ID
- NCT00120458
- Acronym / sponsor ID
- R21AT002289-01A1
- Conditions
- Generalized Anxiety Disorder, Menopause
- Keywords
- Black Cohosh, Cimicifuga, Anxiety, Women, Complementary and Alternative Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Study start
- Jul 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Jul 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 will determine the effectiveness of the herb black cohosh for treating menopause-related anxiety symptoms in women.
Study hypotheses: 1) Black cohosh will have a superior anti-anxiety effect compared to placebo. 2) Black cohosh will have a comparable safety profile to that of placebo.
Detailed description
During menopause, up to 90% of women will experience symptoms of anxiety, such as nervousness, irritability, fatigue, muscle aches, depression, and low libido. Concern over the safety and effectiveness of hormone replacement therapy for relieving these symptoms has caused many women to seek alternative medical treatments. Data suggest that black cohosh has a direct effect on the neurotransmitters and receptors involved in anxiety. This study will determine whether black cohosh can effectively treat anxiety symptoms in menopausal women.
This study will last 12 weeks. Participants will be randomly assigned to receive either black cohosh or placebo daily for the duration of the study. Self-report scales will be used to assess participants' anxiety symptoms and quality of life at the beginning and end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Black cohoshAnxiolytic Therapy |
| 2 | Placebo comparator | Dietary Supplement: Black cohoshAnxiolytic Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently experiencing menopause or postmenopausal
- Have symptoms of menopause-related anxiety
Key exclusion criteria (14 listed)
- Any form of generalized anxiety disorder (GAD) unrelated to menopause
- Onset of GAD at least 3 years prior to menopause or at least 5 years after menstruation has stopped
- Alcohol or drug dependence within 3 months prior to study entry
- Allergy to black cohosh
- History of hormone replacement therapy
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 |
|---|---|---|
| Black cohosh32 to 128 mg (black cohosh) 1 to 4 capsules daily (placebo) | Dietary supplement | 1, 2 |
Primary outcome
Score on Hamilton Anxiety Rating Scale
Time frame: 12 Weeks
1 secondary outcome
Quality of life and functional outcome ratings
Time frame: 12 Weeks
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 2 Mar 2010.
- Derived from this study: PubMed 19745648Amsterdam JD, Yao Y, Mao JJ, Soeller I, Rockwell K, Shults J. Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause. J Clin Psychopharmacol. 2009 Oct;29(5):478-83. doi: 10.1097/JCP.0b013e3181b2abf2.
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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.
Jay D. Amsterdam, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Black cohosh in people with Generalized Anxiety Disorder and Menopause, run by University of Pennsylvania 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 2 inclusion and 14 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 2 Mar 2010. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Score on Hamilton Anxiety Rating Scale (time frame: 12 Weeks). 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 NCT00120458, 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 2 Mar 2010.