Long Term Chamomile Therapy for Anxiety
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Chamomile (Matricaria recutita)
Intervention description: 500 mg 3 times daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Anxiety; Chamomile; Herbal Remedy; Complementary and Alternative Medicine

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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