Delving into the Latest Updates on Citalopram Hydrobromide/Pipamperone Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Citalopram/pipamperone, PipCit, Pipamperone/citalopram

+ [1]

Target

5-HT2A receptor x D2 receptor x D4 receptor x SERT

Action

antagonists, inhibitors

Mechanism

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

Nervous System Diseases

Active Indication-

Inactive Indication

Depressive Disorder, MajorMajor depressive disorder, moderate (MDD)

Originator Organization

PharmaNeuroBoost NV

Active Organization-

Inactive Organization

PharmaNeuroBoost NV

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC20H22BrFN2O

InChIKeyWIHMBLDNRMIGDW-UHFFFAOYSA-N

CAS Registry59729-32-7

View All Structures (2)

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

NCT00672659

/ CompletedPhase 2

Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)

The primary objective is to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD will improve the efficacy of citalopram 40 mg in these patients.
Secondary objectives are to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD:
Will increase the rate of resolution of symptoms with citalopram 40 mg.
Show the combined product to be safe and tolerable.
Patients are scheduled to receive study medication for eight weeks and a final follow-up check will be carried out 28 days after completing the study.
All patients will receive active citalopram from baseline and will be randomised to receive either active pipamperone or a placebo equivalent for eight weeks during which time they will attend for 6 study visits.

Start Date01 Feb 2008

Sponsor / Collaborator

PharmaNeuroBoost NV

100 Clinical Results associated with Citalopram Hydrobromide/Pipamperone Hydrochloride

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100 Translational Medicine associated with Citalopram Hydrobromide/Pipamperone Hydrochloride

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

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2

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 ; E. Buntinx ; A. F. Schatzberg ; 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).

100 Deals associated with Citalopram Hydrobromide/Pipamperone Hydrochloride

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Major	Phase 3	Canada	PharmaNeuroBoost NV	01 Sep 2011
Depressive Disorder, Major	Phase 3	United States	PharmaNeuroBoost NV	01 Sep 2011
Major depressive disorder, moderate (MDD)	Phase 3	United Kingdom	PharmaNeuroBoost NV	01 Feb 2008

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Clinical Result

Indication

Phase

Evaluation

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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)	fsttvlfajq(keukqpyctg) = ngfybahcyr xwlwmedlee (wopctpoxny, xwujechwat - mkunsvhbnc) View more	-	07 Apr 2022
				citalopram (Citalopram)	fsttvlfajq(keukqpyctg) = bvurxnlmjw xwlwmedlee (wopctpoxny, dukogncjsm - jqpihsmmaw) View more