Long Term Chamomile Therapy for Anxiety

Completed · Phase 3 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

Prior research has shown that chamomile may be an effective, short-term anti-anxiety treatment. This study will examine the initial and long-term benefits of chamomile extract therapy for the prevention of recurrent anxiety disorder.

Key facts

Study ID

NCT01072344

Run by

University of Pennsylvania

People needed

180

Starts

2010-02-01

Expected to finish

2015-06-01

Last updated by the study team

2017-07-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women at least 18 years old (all races and ethnicity)
• DSM IV diagnosis of GAD as the primary anxiety disorder
• Baseline GAD-7 score ≥ 10
• Baseline CGI/S score at least 4
• Not taking anti-anxiety medication (e.g., Benzodiazepines, buspirone, antidepressants)
• Not taking antidepressant, mood stabilizer, or tranquilizer therapy for a prior DSM IV Axis I mood disorder that is in remission
• Able to understand and provide informed consent
• Able to participate in a 38-week study

You may not qualify if…

• Patients < 18 years old
• Primary DSM IV Axis I anxiety disorder other than GAD (e.g., panic disorder with or without agoraphobia, phobia disorder, acute stress disorder, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, substance-induced anxiety disorder)
• Current DSM IV Axis I psychotic disorder
• Substance abuse or dependence within the prior 3 months
• Current DSM IV Axis I bipolar or major depressive disorder [Note: Patients with co-morbid depressive disorder NOS (e.g., minor depression, recurrent brief depressive disorder, or premenstrual dysphoric disorder (PMDD)] will not be excluded
• Unstable medical condition
• Allergy to chamomile
• Documented allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum)
• Allergic to mugwort or birch pollen
• Concurrent anti-anxiety 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)
• Concurrent use of established antidepressant, mood stabilizer, or tranquilizer therapy for pre-existing affective disorder. [Note: Patients with a history of affective disorder (in remission) who are not currently taking antidepressant, mood stabilizer, or tranquilizer therapy are not excluded from the trial]
• Women of child-bearing potential not willing to use a medically proven form of contraception
• Positive pregnancy test
• Actively suicidal or suicide attempt within the preceding 12 months

Where it is running

• Depression Research Unit — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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