Clinical trialNCT01312922CompletedPhase 3Interventional

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

SponsorPharmaNeuroBoost N.V.Enrollment555Major Depressive Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Max Schmauss, MD
Bezirkskrankenhaus Augsburg Klinik für Psychiatrie, Psychotherapie und Psychosomatik Dr.-Mack-Straße 1 D-86156 Augsburg, Germany
Study Chair
clinicaltrials.gov ↗
Michael E Thase, MD
Director, Mood and Anxiety Section; 3535 Market Street, Suite 670; Philadelphia, PA 19104-3309, United States of America
Study ChairKOL profile →
clinicaltrials.gov ↗
Philippe Lemmens, PhD
Pharmaneuroboost N.V. Alkerstraat 30A B-3570 Alken, Belgium
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

31 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Site 201
Kelowna, British Columbia, Canada
Site 202
Penticton, British Columbia, Canada
Site 205
Chatham, Ontario, Canada
Site 203
Mississauga, Ontario, Canada
Site 204
Mississauga, Ontario, Canada

United States

Site 103
Glendale, California, United States
Site 101
National City, California, United States
Site 113
Riverside, California, United States
Site 106
San Diego, California, United States
Site 116
San Diego, California, United States
Site 112
Fort Myers, Florida, United States
Site 135
Miami, Florida, United States
Site 108
Winter Park, Florida, United States
Site 133
Atlanta, Georgia, United States
Site 128
Smyrna, Georgia, United States
Site 132
Libertyville, Illinois, United States
Site 117
Schaumburg, Illinois, United States
Site 110
Baltimore, Maryland, United States
Site 109
Flowood, Mississippi, United States
Site 115
New York, New York, United States
Site 126
Beachwood, Ohio, United States
Site 127
Cincinnati, Ohio, United States
Site 124
Middleburg Heights, Ohio, United States
Site 105
Allentown, Pennsylvania, United States
Site 123
Media, Pennsylvania, United States
Site 122
Philadelphia, Pennsylvania, United States
Site 119
Austin, Texas, United States
Site 104
Dallas, Texas, United States
Site 102
Wichita Falls, Texas, United States
Site 107
Kirkland, Washington, United States
Site 134
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Citalopram →PNB01 fixed dose combination of pipamperone and citalopramPipamperone

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Sept 2011
Primary completion: 30 Nov 2012
Completion: 31 Dec 2012
Last update posted: 7 Apr 2022
Registered enrollment: 555
Registry id: NCT01312922

Cross-registrations

EU-CTR / CTIS (EudraCT)2011-001190-11

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.