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.

开始日期2011-09-01

申办/合作机构

PharmaNeuroBoost NV

100 项与氢溴酸西酞普兰/盐酸匹泮哌隆相关的临床结果

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100 项与氢溴酸西酞普兰/盐酸匹泮哌隆相关的转化医学

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100 项与氢溴酸西酞普兰/盐酸匹泮哌隆相关的专利（医药）

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项与氢溴酸西酞普兰/盐酸匹泮哌隆相关的文献（医药）

2011-10-01·Psychological medicine1区 · 医学

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

1区 · 医学

Article

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

Background:

Selective 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.

Method:

An 8-week, randomized, double-blind study in patients with major depressive disorder was carried out.

Results:

The 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).

Conclusions:

Although 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.

2010-02-01·IDrugs : the investigational drugs journal

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

Article

作者: 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).

Arzneimittel-Forschung

Pharmacokinetics of Pipamperone from Three Different Tablet Formulations

Article

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

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 项与氢溴酸西酞普兰/盐酸匹泮哌隆相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
重度抑郁症	临床3期	美国	PharmaNeuroBoost NV	2011-09-01
重度抑郁症	临床3期	加拿大	PharmaNeuroBoost NV	2011-09-01
抑郁症	临床3期	-	PharmaNeuroBoost NV	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01312922 (CTgov)	临床3期	重度抑郁症	555	PNB01 fixed dose combination of pipamperone and citalopram (PNB01)	鑰鹽醖願選廠鑰糧窪齋(壓鬱糧選鹹壓憲網窪獵) = 醖構齋廠衊餘鹹窪範願膚網築範繭壓膚鹹鏇衊 (觸獵憲膚壓憲膚簾獵憲, 鬱遞糧積製積獵範艱壓 ~ 鑰顧範窪糧鹽範壓簾鬱) 更多	-	2022-04-07
				citalopram (Citalopram)	鑰鹽醖願選廠鑰糧窪齋(壓鬱糧選鹹壓憲網窪獵) = 鏇範蓋顧憲構齋鬱蓋窪膚網築範繭壓膚鹹鏇衊 (觸獵憲膚壓憲膚簾獵憲, 築窪築餘窪窪網鏇構艱 ~ 壓鬱廠壓築夢窪顧鹽獵) 更多