NCT00645983

Brief Summary

This study will determine the effectiveness of chamomile extract for treating generalized anxiety disorder. Study hypotheses: 1)Chamomile extract will have a superior anti-anxiety effect compared to placebo. 2)Chamomile will have a comparable safety profile to that of placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

Enrollment Period

2.3 years

First QC Date

March 26, 2008

Last Update Submit

December 1, 2009

Conditions

Generalized Anxiety Disorder

Keywords

ChamomileAnxietyComplementary and Alternative Medicine

Outcome Measures

Primary Outcomes (1)

  • Score on Hamilton Anxiety Rating Scale

    8 Weeks

Secondary Outcomes (1)

  • Beck Anxiety Index Rating

    8 Weeks

Study Arms (2)

1

EXPERIMENTAL

Chamomile Extract

Dietary Supplement: Chamomile Extract

2

PLACEBO COMPARATOR

Anxiolytic Therapy

Other: Placebo

Interventions

Chamomile ExtractDIETARY_SUPPLEMENT

220 mg - 1100 mg daily

1
PlaceboOTHER

1 to 5 capsules daily

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women \> 18 years of age (all races and ethnicity)
  • Meet DSM IV criteria for GAD
  • Mild to moderate symptom severity
  • HAM-A score \> 8
  • Not receiving anti-anxiety medication (e.g., benzodiazepine, venlafaxine, buspirone, or SSRI)
  • Able to understand and provide signed informed consent
  • Able to participate in a 8-week study

You may not qualify if:

  • Patients \< 18 years old
  • Current DSM IV Axis I diagnosis of Major Depressive Disorder, Bipolar Disorder, Panic Disorder (with or without agoraphobia), Specific Phobia Disorder, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Acute Stress Disorder, Substance-Induced Anxiety Disorder, Schizophrenia, Other psychotic disorders, Current alcohol or drug abuse, Alcohol or drug dependence within 3 months, \[NB: Patients with co-morbid DSM IV Axis I Depressive Disorders NOS (e.g., minor depressive disorder, premenstrual dysphoric disorder, and recurrent brief depressive disorder will not be excluded)\]
  • Unstable medical condition (e.g., hypothyroidism, hypertension, myocardial infarction within 1 month, neoplastic condition)
  • Allergy to Chamomile preparation
  • Allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum)
  • Allergy to mugwort, RAST, or birch tree pollen
  • Concurrent 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)
  • Women of child-bearing potential not willing to employ a medically proven form of contraception (e.g., condoms, oral contraceptives, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depression Research Unit, Universityof Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104-3309, United States

Location

Related Publications (1)

  • Amsterdam JD, Li Y, Soeller I, Rockwell K, Mao JJ, Shults J. A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder. J Clin Psychopharmacol. 2009 Aug;29(4):378-82. doi: 10.1097/JCP.0b013e3181ac935c.

    PMID: 19593179DERIVED

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety Disorders

Interventions

Chamomile extract

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Jay D. Amsterdam, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 28, 2008

Study Start

October 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations

US(1)