CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 555 enrolled
Drug / intervention
PNB01 fixed dose combination of pipamperone and citalopram +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01312922
NCT01312922Phase 3Completed
CompareCT.gov

Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in the Treatment of Moderate to Severe Major Depressive Disorder (MDD): a Randomized, Double-blind Phase III Study of 10 Weeks

PharmaNeuroBoost N.V.·interventional·Posted Mar 11, 2011·Updated Apr 7, 2022

In Brief

A Phase 3 clinical trial evaluating PNB01 fixed dose combination of pipamperone and citalopram, Citalopram, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 555 participants across 31 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2011
Enrollment StartSep 1, 2011
Primary CompletionNov 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.3 years ago

Interventions

PNB01 fixed dose combination of pipamperone and citalopramdrug

oral once daily administration

Citalopramdrug

oral once daily administration

Pipamperonedrug

oral once daily administration