Chamomile Therapy for Generalized Anxiety

• ClinicalTrials.gov Identifier: NCT00645983
• Recruitment Status: Completed
• First Posted: March 28, 2008
• Last Update Posted: December 2, 2009
• Sponsor: University of Pennsylvania
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Office of Dietary Supplements (ODS)
• Information provided by: University of Pennsylvania

Study Description

Brief Summary:

This study will determine the effectiveness of chamomile extract for treating generalized anxiety disorder.

Study hypotheses: 1)Chamomile extract will have a superior anti-anxiety effect compared to placebo. 2)Chamomile will have a comparable safety profile to that of placebo.

Condition or disease	Intervention/treatment	Phase
Generalized Anxiety Disorder	Dietary Supplement: Chamomile Extract; Other: Placebo	Phase 4

Detailed Description:

We propose to investigate the anti-anxiety activity of Chamomile. Among the many uses of Chamomile, its use as an anti-anxiety herb is universal. Despite its widespread use and acceptance, there have been no studies evaluating the safety and anti-anxiety efficacy of Chamomile in human subjects. Given this lack of controlled clinical data, we propose a pilot study of Chamomile safety and efficacy in mild anxiety, and propose using the data as a basis for statistically powering a future R01 application. We will ask: Is Chamomile a safe and effective alternative treatment for Generalized Anxiety Disorder (GAD)? To do this, 60 patients with a diagnosis of mild to moderate GAD will receive double-blind treatment for 8 weeks with either (i) Chamomile extract, or (ii) placebo. We hypothesize that Chamomile will have a superior anti-anxiety efficacy compared to placebo, and a comparable safety profile to placebo.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Chamomile Therapy for Generalized Anxiety Disorder
• Study Start Date: October 2005
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: January 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Chamomile Extract	Dietary Supplement: Chamomile Extract; 220 mg - 1100 mg daily
Placebo Comparator: 2; Anxiolytic Therapy	Other: Placebo; 1 to 5 capsules daily

Outcome Measures

Primary Outcome Measures :

1. Score on Hamilton Anxiety Rating Scale [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :

1. Beck Anxiety Index Rating [ Time Frame: 8 Weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Men and women > 18 years of age (all races and ethnicity)

Meet DSM IV criteria for GAD

Mild to moderate symptom severity

HAM-A score > 8

Not receiving anti-anxiety medication (e.g., benzodiazepine, venlafaxine, buspirone, or SSRI)

Able to understand and provide signed informed consent

Able to participate in a 8-week study

Exclusion Criteria:

Patients < 18 years old

Current DSM IV Axis I diagnosis of Major Depressive Disorder, Bipolar Disorder, Panic Disorder (with or without agoraphobia), Specific Phobia Disorder, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Acute Stress Disorder, Substance-Induced Anxiety Disorder, Schizophrenia, Other psychotic disorders, Current alcohol or drug abuse, Alcohol or drug dependence within 3 months, [NB: Patients with co-morbid DSM IV Axis I Depressive Disorders NOS (e.g., minor depressive disorder, premenstrual dysphoric disorder, and recurrent brief depressive disorder will not be excluded)]

Unstable medical condition (e.g., hypothyroidism, hypertension, myocardial infarction within 1 month, neoplastic condition)

Allergy to Chamomile preparation

Allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum)

Allergy to mugwort, RAST, or birch tree pollen

Concurrent tranquilizer, antidepressant or mood stabilizer therapy

Concurrent use of over-the-counter anti-anxiety and/or antidepressant preparations (e.g., Chamomile, St. John's Wort, Kava kava)

Women of child-bearing potential not willing to employ a medically proven form of contraception (e.g., condoms, oral contraceptives, etc)

Contacts and Locations

Locations

United States, Pennsylvania

Depression Research Unit, Universityof Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States, 19104-3309

Sponsors and Collaborators

University of Pennsylvania

National Center for Complementary and Integrative Health (NCCIH)

Office of Dietary Supplements (ODS)

Investigators

• Principal Investigator: Jay D. Amsterdam, M.D.; University of Pennsylvania

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Amsterdam JD, Li Y, Soeller I, Rockwell K, Mao JJ, Shults J. A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder. J Clin Psychopharmacol. 2009 Aug;29(4):378-82. doi: 10.1097/JCP.0b013e3181ac935c.

• Responsible Party: Jay D. Amsterdam, M.D., Professor, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00645983
• Other Study ID Numbers: R21AT001916 ( U.S. NIH Grant/Contract ); R21AT001916 ( U.S. NIH Grant/Contract )
• First Posted: March 28, 2008
• Last Update Posted: December 2, 2009
• Last Verified: December 2009

Keywords provided by University of Pennsylvania:

Chamomile; Anxiety; Complementary and Alternative Medicine

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders