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Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

Primary Purpose

Generalized Anxiety Disorder, Menopause

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Black cohosh
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Black Cohosh, Cimicifuga, Anxiety, Women, Complementary and Alternative Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Currently experiencing menopause or postmenopausal Have symptoms of menopause-related anxiety Exclusion Criteria: 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 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

Sites / Locations

  • Depression Research Unit, University of Pennsylvania School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Anxiolytic Therapy

Anxiolytic Therapy

Outcomes

Primary Outcome Measures

Score on Hamilton Anxiety Rating Scale

Secondary Outcome Measures

Quality of life and functional outcome ratings

Full Information

First Posted
July 14, 2005
Last Updated
March 1, 2010
Sponsor
University of Pennsylvania
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
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1. Study Identification

Unique Protocol Identification Number
NCT00120458
Brief Title
Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety
Official Title
Black Cohosh Therapy for Menopause-Related Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pennsylvania
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Menopause
Keywords
Black Cohosh, Cimicifuga, Anxiety, Women, Complementary and Alternative Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Anxiolytic Therapy
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Anxiolytic Therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Black cohosh
Intervention Description
32 to 128 mg (black cohosh) 1 to 4 capsules daily (placebo)
Primary Outcome Measure Information:
Title
Score on Hamilton Anxiety Rating Scale
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Quality of life and functional outcome ratings
Time Frame
12 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently experiencing menopause or postmenopausal Have symptoms of menopause-related anxiety Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay D. Amsterdam, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression Research Unit, University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-3309
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19745648
Citation
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.
Results Reference
derived

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Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

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