Contact information
Type
Scientific
Primary contact
Mr Hertzen Hokwerda
ORCID ID
Contact details
Tolhuislaan 11 - 13
Gorredijk
8401 GA
Netherlands
+31 (0) 513 469 369
h.hokwerda@bional.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
Study hypothesis
Ansolin is equal to placebo in treating depression
Ethics approval
Pakistan psychiatric research centre
Study design
Double blind, randomised, multicentre, placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Hypericum perforatum (St Johns Wort) and Passiflora incarnata (Passion flower)
Primary outcome measures
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 trial start date
03/07/2004
Overall trial end date
01/05/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
03/07/2004
Recruitment end date
01/05/2006
Locations
Countries of recruitment
Pakistan
Trial participating centre
Tolhuislaan 11 - 13
Gorredijk
8401 GA
Netherlands
Sponsor information
Organisation
Bional Holding BV (The Netherlands)
Sponsor details
Tolhuislaan 11-15
Gorredijk
8401 GA
Netherlands
+31 (0) 513 469 369
h.hokwerda@bional.nl
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Bional Holding BV
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary