Long Term Chamomile Therapy for Anxiety

NCT01072344 | Completed Phase 3 Results DMC

• 1 other identifier: AT005074
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Generalized Anxiety Disorder

Keywords

Anxiety; Chamomile; Herbal Remedy; Complementary and Alternative Medicine

Outcome Measures

Primary Outcomes (1)

• Time to Relapse in Each Treatment Condition.

  The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Relapse is dichotomously defined as an increase in CGI/S (a clinician-rated global measure of anxiety's severity) score from ≤ 3 (at study visit 6) to ≥ 4 (on two consecutive scheduled or unscheduled study visits ≥ 2 weeks apart) plus meeting DSM IV-TR criteria for GAD (minus the 6-month time criterion).

  26 weeks

Secondary Outcomes (4)

• The Proportion of Subjects in Each Treatment Condition Who Relapse.

  26 weeks

• Frequency, Severity, and Duration of Treatment-emergent Adverse Events.

  26 weeks

• Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition.

  26 weeks

• Frequency of Early Study Discontinuation in Each Treatment Condition.

  26 weeks

Study Arms (2)

Chamomile Extract

EXPERIMENTAL

Pharmaceutical grade oral chamomile extract.

Drug: Chamomile (Matricaria recutita)

Placebo

PLACEBO COMPARATOR

Pharmaceutical grade lactose monohydrate.

Drug: Chamomile (Matricaria recutita)

Interventions

Chamomile (Matricaria recutita) DRUG

500 mg 3 times daily

Also known as: Chamomile

Chamomile Extract; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Depression Research Unit

Philadelphia, Pennsylvania, 19104-3309, United States

Location

Related Publications (3)

• Keefe JR, Guo W, Li QS, Amsterdam JD, Mao JJ. An exploratory study of salivary cortisol changes during chamomile extract therapy of moderate to severe generalized anxiety disorder. J Psychiatr Res. 2018 Jan;96:189-195. doi: 10.1016/j.jpsychires.2017.10.011. Epub 2017 Oct 16.

  PMID: 29080520 DERIVED

• Mao JJ, Xie SX, Keefe JR, Soeller I, Li QS, Amsterdam JD. Long-term chamomile (Matricaria chamomilla L.) treatment for generalized anxiety disorder: A randomized clinical trial. Phytomedicine. 2016 Dec 15;23(14):1735-1742. doi: 10.1016/j.phymed.2016.10.012. Epub 2016 Oct 24.

  PMID: 27912875 DERIVED

• Keefe JR, Amsterdam J, Li QS, Soeller I, DeRubeis R, Mao JJ. Specific expectancies are associated with symptomatic outcomes and side effect burden in a trial of chamomile extract for generalized anxiety disorder. J Psychiatr Res. 2017 Jan;84:90-97. doi: 10.1016/j.jpsychires.2016.09.029. Epub 2016 Sep 30.

  PMID: 27716513 DERIVED

Related Links

• University of Pennsylvania Depression Research Unit Website

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Chamomile extract

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Jun Mao
• Organization: Memorial Sloan Kettering Cancer Center

maoj@mskcc.org

646-888-0866

Study Officials

• Jun J Mao, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 22, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 6, 2017
• Results First Posted: July 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)