Chamomile Therapy for Generalized Anxiety

Completed · Phase 4 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT00645983

Run by

University of Pennsylvania

People needed

61

Starts

2005-10-01

Expected to finish

2008-01-01

Last updated by the study team

2009-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Depression Research Unit, Universityof Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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