drugset / Trial / NCT01312922

Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in Major Depressive Disorder (MDD)

NCT01312922

Phase 3 Completed 555 enrolled PharmaNeuroBoost N.V.
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

EvaluationDrugModalityDoseRoute
Comparator Citalopram Small molecule 40 mg Oral
Comparator Pipamperone Small molecule 15 mg Oral