A Phase II randomized, double-blind, parallel-group, multi-site, placebo controlled fixed-dose study of Echinaceae angustifoliae root dry extract in 24 outpatients with generalized anxiety disorder (GAD)

• Conditions: Generalized Anxiety Disorder (GAD); MedDRA version: 12.1Level: LLTClassification code 10018075Term: Generalised anxiety disorder

• Registration Number: EUCTR2010-019369-27-HU
• Lead Sponsor: Anxiofit Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) based on a structured Mini-International Neuropsychiatric Interview
2. Subjects must have a HAM-A total score =17 and =25 at the screening (V1) and randomization (V2) visits. On items 1 (anxious mode) and 2 (tension) a score of 2 or more will be required.
3. Subjects must have a total score of =10 on Beck scale
Subject must have a =3 point on CGI
5. Otherwise healthy men or non-pregnant, non-lactating women (women must be using a hormonal or barrier method of contraception or be postmenopausal or surgically sterilized). Healthy is defined as no other clinically relevant abnormalities identified by a detailed medical history, full physical examination including sitting blood pressure (BP) and heart rate measurement.
6. Age 18 to 60 years, inclusive.
7. All women must have negative pregnancy tests at the Screening (V1) and Randomization (V2) visits.
8. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed and understood of all pertinent aspects of the study.
9. Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects with evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
2. Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses:
o Major depressive disorder;
o Obsessive compulsive disorder;
o Panic disorder;
o Agoraphobia;
o Posttraumatic stress disorder;
o Anorexia;
o Bulimia;
o Caffeine-induced anxiety disorder;
o Alcohol or substance abuse or dependence unless in full remission for at least 6 months;
o Social anxiety disorder
3. Any of the following past or current DSM-IV Axis I diagnoses:
o Schizophrenia;
o Psychotic disorder;
o Delirium, dementia, amnestic, and other clinically significant cognitive disorders;
o Bipolar or schizoaffective disorder;
o Cyclothymic disorder;
o Dissociative disorders
Antisocial or borderline personality disorder.
5. Serious suicidal risk per the clinical investigator's judgment. (Note: The Suicidality module of the MINI diagnostic interview should be used as aid to the assessment of suicidality, but does not replace overall clinical judgment in determination of suicidal risk).
6. Current use of psychotropic medications (ie, drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 5 weeks of randomization. In the event of inadvertent administration of psychotropic medications during the 2 weeks prior to randomization, continued eligibility will be assessed on a case by case basis by the investigator and the medical monitor.
7. Use of drugs, supplements, prescription or nonprescription, or food that have psychoactive properties. In the event of inadvertent use of such products during the 2 weeks prior to randomization, continued eligibility will be assessed on a case by case basis by the investigator and the medical monitor.
8. Subjects who have been treated with monoamine oxidase inhibitors in the 14 days prior to the baseline visit.
9. Regular use of benzodiazepines during the 3 months prior to Screening (for at least 5 out of 7 days per week).
10. Subjects initiating formal psychotherapy within 3 month prior to screening who intend to continue formal psychotherapy during the study. This includes psychodynamic, cognitive, and interpersonal therapies.
11. Positive drug tests at Screening or Randomization visits for any of the following substances or classes of compounds: amphetamines, barbiturates, opiates, benzodiazepines, sedatives and hypnotics, cocaine, phencyclidine (PCP), cannabinoids, or other illegal or illicit drugs.
12. Any condition possibly affecting drug absorption (eg, gastrectomy).
13. Subjects with a current seizure disorder.
14. Subjects with a history of life-threatening neoplasms within 5 years prior to study entry, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.
15. Subjects with earlier known hypothyroidism or hyperthyroidism, except subjects who are euthyroid and have been on stable doses of thyroid replacement for 6 months or more.
16. Subjects with any earlier diagnosed and at the time of enrolment clinically unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disorder.
17. History of allergy or intolerance to any Echinaceae product.
18. Pregnant o

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified