Effectiveness of Hypericum perforatum and Passiflora incarnata extract combination for treatment of depression and accompanied anxiety
ISRCTN | ISRCTN46080812 |
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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
Scientific
Tolhuislaan 11 - 13
Gorredijk
8401 GA
Netherlands
Phone | +31 (0) 513 469 369 |
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h.hokwerda@bional.nl |
Study information
Study design | Double blind, randomised, multicentre, placebo controlled trial |
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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 |
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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
8401 GA
Netherlands
Sponsor information
Bional Holding BV (The Netherlands)
Industry
Industry
Tolhuislaan 11-15
Gorredijk
8401 GA
Netherlands
Phone | +31 (0) 513 469 369 |
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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 | |
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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 |