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

ISRCTN	ISRCTN46080812
DOI	https://doi.org/10.1186/ISRCTN46080812
Secondary identifying numbers	1

Submission date: 19/06/2006
Registration date: 13/07/2006
Last edited: 13/07/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Hertzen Hokwerda
Scientific

Tolhuislaan 11 - 13
Gorredijk
8401 GA
Netherlands

Phone	+31 (0) 513 469 369
Email	h.hokwerda@bional.nl

Study information

Study design	Double blind, randomised, multicentre, placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Scientific title
Study objectives	Ansolin is equal to placebo in treating depression
Ethics approval(s)	Pakistan psychiatric research centre
Health condition(s) or problem(s) studied	Depressive states
Intervention	This is a randomised, double blind, multicentre, parallel group, placebo and active controlled comparison of the efficacy and safety of Ansolin in ambulatory, mildly or moderately depressed patients of eight week duration with a follow-up after four weeks. After obtaining informed consent patients will complete a pre-study evaluation to assess their suitability to participate. They start with a single-blind placebo period of one week duration and the severity of the depressive symptoms is reassessed thereafter. Eligible patients who do not improve more than 20% on the HAMD-17 will receive one of two treatments: ansolin (containing Hypercicum perforatum and Passiflora incarnata), or a placebo. Patients will be stratified according to their HAMD score (two strata: HAMD total score of 14-17 or 18-24) and centre (three strata). Blindness will be assured by applying the placebo-verum technique. Treatment with double blind medication will be ended, when the clinical condition worsens during treatment or when improvement stagnates in such a degree that the best interest of the patient is not served by continuation. Both decisions are at the discretion of the investigator. At this moment treatment is initiated with the drugs preferred by doctor and patient. Preferably, after discontinuation of the double-blind medication all assessment will take place as scheduled. The clinical trial will be ended, when less than 25% of the required number of patients is included within eight months after the initiation of the trial.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Hypericum perforatum (St Johns Wort) and Passiflora incarnata (Passion flower)
Primary outcome measure	The efficacy of ansolin in mild to moderate severe depressive states.
Secondary outcome measures	The efficacy of ansolin in the accompained anxiety in depressive states.
Overall study start date	03/07/2004
Completion date	01/05/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	150
Key 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
Key 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
Date of first enrolment	03/07/2004
Date of final enrolment	01/05/2006

Locations

Countries of recruitment

Netherlands
Pakistan

Study participating centre

Tolhuislaan 11 - 13

Gorredijk
8401 GA
Netherlands

Sponsor information

Bional Holding BV (The Netherlands)
Industry

Tolhuislaan 11-15
Gorredijk
8401 GA
Netherlands

Phone	+31 (0) 513 469 369
Email	h.hokwerda@bional.nl
Website	www.bional.nl

Funders

Funder type

Industry

Bional Holding BV

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan