Track topics on Twitter Track topics that are important to you
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.
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).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Generalized Anxiety Disorder
Chamomile (Matricaria recutita)
Depression Research Unit
National Center for Complementary and Alternative Medicine (NCCAM)
Published on BioPortfolio: 2014-07-24T14:07:25-0400
Generalized Anxiety Disorder (GAD) has high prelevance (up to 8.5%; Roy-Byrne & Wagner, 2004) and leads to functional impairment (Wittchen et al., 2002; Ballenger et al., 2001). Researcher...
The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder
The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD)
The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.
anxiety disorder is one of the major public health problems worldwide. 25% of people experience anxiety disorders throughout life. Generalized anxiety disorder (GAD) is known as the most p...
Attention-deficit/hyperactivity disorder (ADHD) is often comorbid with anxiety disorders such as generalized anxiety disorder, but the best approach to treat this comorbidity in adults has yet to be d...
Fear conditioning is implicated as a central psychopathological mechanism of anxiety disorders. People with anxiety disorders typically demonstrate reduced affective discrimination between conditioned...
This study explored the magnitude and clinical correlates of anxiety in three groups of patients with major depressive disorder (MDD): those with comorbid anxiety disorders (the COM group), those with...
Patients with generalized anxiety disorder (GAD) usually present with various neurological symptoms, but the mechanisms remain unclear. We aimed to analyze the characteristics of dynamic cerebral auto...
The purpose of this study was to assess the prevalence and associated factors of generalized anxiety disorder (GAD) in adults using the seven-item GAD scale (GAD-7) and to evaluate the properties of t...
A plant genus of the family ASTERACEAE that is used in folk medicine as CHAMOMILE. Other plants with similar common names include MATRICARIA; TRIPLEUROSPERMUM and ANTHEMIS.
Common name for several daisy-like plants (MATRICARIA; TRIPLEUROSPERMUM; ANTHEMIS; CHAMAEMELUM) native to Europe and Western Asia, now naturalized in the United States and Australia.
A plant genus of the family ASTERACEAE. It is easily confused with related plants with similar common names of Chamomile and Mayweed (MATRICARIA; CHAMAEMELUM; and ANTHEMIS).
A self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD), a diagnostic tool containing modules on multiple mental health disorders including anxiety, alcohol, eating, and somatoform modules. The Patient Health Questionnaire (PHQ-9) is designed specifically for mood/depression scoring each of the 9 DSM-IV criteria based on the mood module from the original PRIME-MD. The Generalized Anxiety Disorder scale (GAD-7) scores 7 common anxiety symptoms.
Anxiety disorder characterized by the persistent and irrational fear, anxiety, or avoidance of social or performance situations.
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...
Psychiatry is the study of mental disorders and their diagnosis, management and prevention. Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...