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Chamomile Therapy for Generalized Anxiety

Primary Purpose

Generalized Anxiety Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Chamomile Extract

Placebo

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Chamomile, Anxiety, Complementary and Alternative Medicine

Eligibility Criteria

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

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)

Sites / Locations

Depression Research Unit, Universityof Pennsylvania School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Chamomile Extract

Anxiolytic Therapy

Outcomes

Primary Outcome Measures

Score on Hamilton Anxiety Rating Scale

Secondary Outcome Measures

Beck Anxiety Index Rating

Full Information

NCT ID

NCT00645983

First Posted

March 26, 2008

Last Updated

December 1, 2009

Sponsor

University of Pennsylvania

Collaborators

National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

1. Study Identification

Unique Protocol Identification Number

NCT00645983

Brief Title

Chamomile Therapy for Generalized Anxiety

Official Title

Chamomile Therapy for Generalized Anxiety Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxiety Disorder

Keywords

Chamomile, Anxiety, 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

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Chamomile Extract

Arm Title

Arm Type

Placebo Comparator

Arm Description

Anxiolytic Therapy

Intervention Type

Dietary Supplement

Intervention Name(s)

Chamomile Extract

Intervention Description

220 mg - 1100 mg daily

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

1 to 5 capsules daily

Primary Outcome Measure Information:

Title

Score on Hamilton Anxiety Rating Scale

Time Frame

8 Weeks

Secondary Outcome Measure Information:

Title

Beck Anxiety Index Rating

Time Frame

8 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jay D. Amsterdam, M.D.

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Depression Research Unit, Universityof Pennsylvania School of Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104-3309

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19593179

Citation

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.

Results Reference

derived

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Chamomile Therapy for Generalized Anxiety

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