Long Term Chamomile Therapy for Anxiety

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Jay Amsterdam, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01072344
First received: February 18, 2010
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Drug: Chamomile (Matricaria recutita)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-Term Chamomile Therapy for Generalized Anxiety Disorder (GAD)

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The primary outcome will be the time to relapse in each treatment condition. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects in each treatment condition who relapse. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Frequency, severity, and duration of treatment-emergent adverse events. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of discontinuation symptoms at the start of double-blind therapy in each treatment condition. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of early study discontinuation in each treatment condition. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: February 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chamomile Extract
Pharmaceutical grade oral chamomile extract.
Drug: Chamomile (Matricaria recutita)
500 mg 3 times daily
Other Name: Chamomile
Placebo Comparator: Placebo
Pharmaceutical grade lactose monohydrate.
Drug: Chamomile (Matricaria recutita)
500 mg 3 times daily
Other Name: Chamomile

Detailed Description:

Anxiety disorders are among the most common psychiatric conditions. They affect up to 25% of the US adult population. Generalized anxiety disorder (GAD) is a chronic, recurrent form of the disorder. Although benzodiazepines and serotonin reuptake inhibitors have become the mainstay therapy of GAD, these drugs are often associated with unwanted side effects, habituation, and withdrawal symptoms. Many individuals decline using conventional drug therapy for financial, cultural, or personal reasons such as the stigma of mental illness. As a result, many individuals will seek alternative therapy for their anxiety symptoms. The identification of effective alternative therapies for GAD would be of particular relevance. Among alternative therapies for anxiety, chamomile has been used as a traditional herbal medicine for its calming effect. It is well tolerated and demonstrates pharmacological activity in animal models of anxiety. Despite its widespread use and availability, there has been only one clinical trial of chamomile safety and efficacy in GAD. The current application seeks to build upon the results of that prior chamomile study. In that 8-week, double-blind, placebo-controlled trial, we found a significant superiority of chamomile (vs. placebo) in reducing GAD symptoms. We also found chamomile to be exceedingly well tolerated (vs. placebo). The current application seeks to extend these promising preliminary results by conducting a randomized, double-blind, parallel group, placebo-substitution, long-term safety and efficacy study of chamomile in preventing GAD relapse. For specific aim #1 we will ask: "Does long-term chamomile therapy (vs. placebo) prolong the time to relapse of anxiety symptoms following recovery from GAD?" To answer this question, 180 patients with moderate to severe GAD will receive open-label chamomile extract 500-1,500 mg daily for 8 weeks. Responders to chamomile, who remain well for 4 additional weeks of consolidation therapy, will be randomized to double-blind continuation therapy with chamomile 500-1,500 mg daily or placebo for an additional 26 weeks. We hypothesize that continuation chamomile therapy will result in a prolonged time to relapse (vs. placebo). For specific aim #2 we will ask: "What is the relative safety and tolerability of long-term chamomile therapy (vs. placebo) in patients who have recovered from GAD?" To answer this question, we will examine the following outcome measures: (i) the proportion of patients in each treatment condition who relapse; (ii) the frequency, severity, and duration of treatment-emergent adverse events; (iii) the frequency of discontinuation symptoms during initial double-blind therapy; and, (iv) the frequency of early study discontinuation. We hypothesize that chamomile therapy will result in a lower proportion of anxiety relapses and a lower study discontinuation rate (vs. placebo). We further hypothesize that chamomile therapy will result in a similar frequency of discontinuation symptoms and treatment-emergent adverse events (vs. placebo).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072344

Contacts
Contact: Jun J Mao, MD 215-662-3462 jun.mao@uphs.upenn.edu
Contact: Maryanne Giampapa, BBA 215-662-2835 mgiampap@mail.med.upenn.edu

Locations
United States, Pennsylvania
Depression Research Unit Recruiting
Philadelphia, Pennsylvania, United States, 19104-3309
Contact: Jun J Mao, MD    215-662-3462    jun.mao@uphs.upenn.edu   
Contact: Maryanne Giampapa, BBA    215-662-2835    mgiampap@mail.med.upenn.edu   
Principal Investigator: Jun J Mao, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Jun J Mao, MD University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Jay Amsterdam, Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01072344     History of Changes
Other Study ID Numbers: AT005074
Study First Received: February 18, 2010
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Anxiety
Chamomile
Herbal Remedy
Complementary and Alternative Medicine

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014