5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor antagonists(Dopamine D2 receptor antagonists), D4 receptor antagonists(Dopamine D4 receptor antagonists)

+ [1]

Therapeutic Areas

Other Diseases

Active Indication-

Inactive Indication

Depressive Disorder, Major

Originator Organization

PharmaNeuroBoost NV

Active Organization-

Inactive Organization

PharmaNeuroBoost NV

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

Structure

Molecular FormulaC20H22BrFN2O

InChIKeyWIHMBLDNRMIGDW-UHFFFAOYSA-N

CAS Registry59729-32-7

View All Structures (2)

Clinical Trials associated with Citalopram Hydrobromide/Pipamperone Hydrochloride

NCT01312922 / CompletedPhase 3

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

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.

Start Date01 Sep 2011

Sponsor / Collaborator

PharmaNeuroBoost NV

100 Clinical Results associated with Citalopram Hydrobromide/Pipamperone Hydrochloride

100 Translational Medicine associated with Citalopram Hydrobromide/Pipamperone Hydrochloride

100 Patents (Medical) associated with Citalopram Hydrobromide/Pipamperone Hydrochloride

Literatures (Medical) associated with Citalopram Hydrobromide/Pipamperone Hydrochloride

01 Oct 2011·Psychological MedicineQ1 · MEDICINE

Citalopram plus low-dose pipamperone versus citalopram plus placebo in patients with major depressive disorder: an 8-week, double-blind, randomized study on magnitude and timing of clinical response

Q1 · MEDICINE

Article

Author: A. McConnachie ; Charles Nemeroff ; A. F. Schatzberg ; E. Buntinx ; L. Haazen ; T. Schlaepfer ; A. G. Wade ; G. M. Crawford

BackgroundSelective serotonin reuptake inhibitors take several weeks to achieve their full antidepressant effects. Post-synaptic 5-HT2A receptor activation is thought to be involved in this delayed therapeutic effect. Pipamperone acts as a highly selective 5-HT2A/D4 antagonist when administered in low doses. The purpose of this study was to compare citalopram 40 mg once daily plus pipamperone 5 mg twice daily (PipCit) versus citalopram plus placebo twice daily for magnitude and onset of therapeutic effect.MethodAn 8-week, randomized, double-blind study in patients with major depressive disorder was carried out.ResultsThe study population comprised 165 patients (citalopram and placebo, n=82; PipCit, n=83) with a mean baseline Montgomery–Asberg Depression Rating Scale (MADRS) score of 32.6 (s.d.=5.5). In the first 4 weeks, more citalopram and placebo than PipCit patients discontinued treatment (18% v. 4%, respectively, p=0.003). PipCit patients had significantly greater improvement in MADRS score at week 1 [observed cases (OC), p=0.021; last observation carried forward (LOCF), p=0.007] and week 4 (LOCF, p=0.025) but not at week 8 compared with citalopram and placebo patients. Significant differences in MADRS scores favoured PipCit in reduced sleep, reduced appetite, concentration difficulties and pessimistic thoughts. Mean Clinical Global Impression–Improvement scores were significantly improved after 1 week of PipCit compared with citalopram and placebo (OC and LOCF, p=0.002).ConclusionsAlthough the MADRS score from baseline to 8 weeks did not differ between groups, PipCit provided superior antidepressant effects and fewer discontinuations compared with citalopram and placebo during the first 4 weeks of treatment, especially in the first week.

01 Feb 2010·IDrugs : the investigational drugs journal

Clinical trials in CNS--SMi's eighth annual conference.

Article

Author: Kirk, Rebecca

The SMi's Eighth Annual Conference on Clinical Trials in CNS, held in London, included topics covering new therapeutic developments in the field of CNS disorders. This conference report highlights selected presentations on emerging clinical targets for the treatment of Alzheimer's disease, achievements of the Alzheimer's Disease Neuroimaging Initiative, computational assessment methods applicable to Alzheimer's disease and to the monitoring of suicidality, the accelerated antidepressive effect of PNB-01 (PharmaNeuroBoost NV; comprising a combination of pipamperone and citalopram), and clinical trials in amyotrophic lateral sclerosis and spinal muscular atrophy. Investigational drugs discussed also include begacestat (Pfizer Inc) and olesoxime (Trophos SA).

Arzneimittelforschung

Pharmacokinetics of Pipamperone from Three Different Tablet Formulations

Article

Author: Sewarte-Ross, Günter ; Potgieter, Gerbrecht ; Kummer, Michael ; Groenewoud, Gerhard ; Hundt, Hans ; Jordaan, Pierre ; Schall, Robert

Twenty-four (24) Caucasian male subjects completed a single-blind, randomised, three-treatment, three-period, cross-over study. In each treatment phase, subjects received a single dose of 144 mg pipamperone dihydrochloride (CAS 2448-68-2) (equivalent to 120 mg pipamperone; CAS 1893-33-0) as either the reference product (3 x 40 mg tablets), test product A (3 x 40 mg tablets) or test product B (1 x 120 mg tablet). Each consecutive dosing was separated by a washout period of 14 days. Following each dosing, venous blood samples were collected over a period of 120 h for the determination of plasma pipamperone concentrations by high-performance liquid chromatography. The most common drug related adverse events, ranging from mild to moderate in intensity, were bloodshot eyes, nasal congestion, dry mouth, hypotension and dizziness. The geometric mean Cmax of pipamperone for both the reference product and test product A was 266 ng/ml and for test product B 263 ng/ml. The geometric mean AUC0-infinity was 3107 ng.h/ml for the reference product, 3229 ng.h/ml for test product A and 3108 ng.h/ml for test product B. The two test products were shown to be bioequivalent to the reference product with respect to all pharmacokinetic variables investigated.

100 Deals associated with Citalopram Hydrobromide/Pipamperone Hydrochloride

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Major	Phase 3	CA	PharmaNeuroBoost NV	01 Sep 2011
Depressive Disorder, Major	Phase 3	US	PharmaNeuroBoost NV	01 Sep 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01312922 (CTgov)	Phase 3	Depressive Disorder, Major	555	PNB01 fixed dose combination of pipamperone and citalopram (PNB01)	gyzeprkezh(pxpmaotyak) = sebwoxoiqv qcxgxaytde (taqarpxcfc, rxuisfsqou - nkeftcmpts) View more	-	07 Apr 2022
				citalopram (Citalopram)	gyzeprkezh(pxpmaotyak) = sbdgaonxvp qcxgxaytde (taqarpxcfc, oxvdqiingg - cqbcywvdzw) View more

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Citalopram Hydrobromide/Pipamperone Hydrochloride

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