Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Chamomile Therapy for Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01072344
Recruitment Status : Completed
First Posted : February 22, 2010
Results First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE February 18, 2010
First Posted Date  ICMJE February 22, 2010
Results First Submitted Date  ICMJE April 28, 2017
Results First Posted Date  ICMJE July 6, 2017
Last Update Posted Date July 6, 2017
Study Start Date  ICMJE February 2010
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2017)
Time to Relapse in Each Treatment Condition. [ Time Frame: 26 weeks ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
The primary outcome will be the time to relapse in each treatment condition. [ Time Frame: 26 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2017)
  • The Proportion of Subjects in Each Treatment Condition Who Relapse. [ Time Frame: 26 weeks ]
    The proportion of subjects in each treatment condition who relapsed after randomization
  • Frequency, Severity, and Duration of Treatment-emergent Adverse Events. [ Time Frame: 26 weeks ]
    We will report the frequency, severity, and duration of treatment-emergent adverse events by treatment arm.
  • Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition. [ Time Frame: 26 weeks ]
    Discontinuation emergent signs and symptoms checklist (DESS) is a patient-rated measure of the presence and severity of discontinuation symptoms occurring after medication discontinuation. %
  • Frequency of Early Study Discontinuation in Each Treatment Condition. [ Time Frame: 26 weeks ]
    This is the # of subjects who discontinued the study during randomization phase due to other reasons.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
  • The Proportion of Subjects in Each Treatment Condition Who Relapse. [ Time Frame: 26 weeks ]
  • Frequency, Severity, and Duration of Treatment-emergent Adverse Events. [ Time Frame: 26 weeks ]
  • Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition. [ Time Frame: 26 weeks ]
  • Frequency of Early Study Discontinuation in Each Treatment Condition. [ Time Frame: 26 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Chamomile Therapy for Anxiety
Official Title  ICMJE Long-Term Chamomile Therapy for Generalized Anxiety Disorder (GAD)
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE Drug: Chamomile (Matricaria recutita)
500 mg 3 times daily
Other Name: Chamomile
Study Arms  ICMJE
  • Experimental: Chamomile Extract
    Pharmaceutical grade oral chamomile extract.
    Intervention: Drug: Chamomile (Matricaria recutita)
  • Placebo Comparator: Placebo
    Pharmaceutical grade lactose monohydrate.
    Intervention: Drug: Chamomile (Matricaria recutita)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2010)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01072344
Other Study ID Numbers  ICMJE AT005074
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jun J Mao, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP