Long Term Chamomile Therapy for Anxiety

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania

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