Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

NCT00120458 | Completed Phase 4 DMC

• 1 other identifier: R21AT002289-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder; Menopause

Keywords

Black Cohosh; Cimicifuga; Anxiety; Women; Complementary and Alternative Medicine

Outcome Measures

Primary Outcomes (1)

• Score on Hamilton Anxiety Rating Scale

  12 Weeks

Secondary Outcomes (1)

• Quality of life and functional outcome ratings

  12 Weeks

Study Arms (2)

1

EXPERIMENTAL

Anxiolytic Therapy

Dietary Supplement: Black cohosh

2

PLACEBO COMPARATOR

Anxiolytic Therapy

Dietary Supplement: Black cohosh

Interventions

Black cohosh DIETARY_SUPPLEMENT

32 to 128 mg (black cohosh) 1 to 4 capsules daily (placebo)

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently experiencing menopause or postmenopausal
• Have symptoms of menopause-related anxiety

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Office of Dietary Supplements (ODS): collaborator

Study Sites (1)

Depression Research Unit, University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104-3309, United States

Location

Related Publications (1)

• 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.

  PMID: 19745648 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

black cohosh root extract

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jay D. Amsterdam, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2005
• First Posted: July 18, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 2, 2010

Record last verified: 2010-03

Locations

US (1)