Condition category
Mental and Behavioural Disorders
Date applied
19/06/2006
Date assigned
13/07/2006
Last edited
13/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

www.bional.nl

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

Publication citations

Additional files

Editorial Notes