drugset / Trial / NCT01312922
Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in Major Depressive Disorder (MDD)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The overall objective of this trial is to demonstrate clinically relevant superior antidepressant efficacy of the fixed dose combination PNB01 (low dose pipamperone and citalopram) over reference antidepressant treatment with citalopram alone, and a low dose of psychoactive pipamperone alone in patients with moderate to severe Major Depressive Disorder. This study was specifically designed to assess patient related outcome (PRO) parameters using an Interactive Voice Response System (IVRS) via telephone.
Timeline
- Start
- 2011-09
- Primary completion
- 2012-11
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Citalopram | Small molecule | 40 mg | Oral |
| Comparator | Pipamperone | Small molecule | 15 mg | Oral |