Depressive states Mental and Behavioural Disorders Depression
Conditions
Interventions
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 o
Sponsors
Bional Holding BV (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of ansolin in mild to moderate severe depressive states. | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy of ansolin in the accompained anxiety in depressive states. | — |
Countries
Pakistan
Outcome results
None listed