Effectiveness of Hypericum perforatum and Passiflora incarnata extract combination for treatment of depression and accompanied anxiety

Completed

• Conditions: Depressive states; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN46080812
• Lead Sponsor: Bional Holding BV (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Male or female patients of eighteen to sixty-five years of age
2. Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of mild to moderate (severe) depressive disorder
3. Total severity score of at least 13 and at most 24 at the 17-item Hamilton rating scale for Depression (HAMD) at the entry visit
4. Able to understand the procedures and agreeing to participate by giving written informed consent

Exclusion Criteria

1. Patients who respond during the first week with a decrease of the total score of the 17-items HAMD of at least 20%
2.
Women of child-bearing potential without adequate birth-control measures
3. Women who are pregnant or breast-feeding
4. Treatment with Monoamine Oxidase (MAO) inhibitors during the last two weeks prior to the entry visit
5. Treatment with any psychotropic drug during at least the week preceding the entry visit
6. Contraindication or history of hypersensitivity to the study drugs
7. Unstable and/or severe organ system diseases, e.g. neurological, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, metabolic, or other
8. History of organ transplantation or Human Immunodeficiency Virus (HIV) positive
9. Usage of immunomodulators, antiretroviral drugs or digoxine
10. Clinical significant abnormalities observed at screening at the discretion of the investigator
11. Substance dependence or abuse according to DSM-IV criteria
12. Bipolar disorder, psychotic features, or any other psychotic disorder
13. Other principal psychiatric diagnosis judged by the investigator to dominate the clinical picture
14. Significant risk for suicide or significant potential for self-harm as judged by the investigator
15. Significant risk for non-compliance with study procedures or drug intake as judged by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified