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Last Updated: September 22, 2020

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CLINICAL TRIALS PROFILE FOR PIPAMPERONE

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Clinical Trials for Pipamperone

Trial ID Title Status Sponsor Phase Summary
NCT00672659 Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD) Completed PharmaNeuroBoost N.V. Phase 2 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: 1. Will increase the rate of resolution of symptoms with citalopram 40 mg. 2. 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.
NCT01312922 Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in Major Depressive Disorder (MDD) Completed PharmaNeuroBoost N.V. Phase 3 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.
NCT01450514 POC Study of Pipamperone Added to Stable Treatment With RIS or PAL in Chronic Schizophrenia Completed PharmaNeuroBoost N.V. Phase 2 This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and clinical outcome of chronic schizophrenic patients with residual, so-called 'positive' symptoms, as well as on cognition, motivation, subjective well-being of patients, negative symptoms, general psychopathological symptoms and safety/tolerability.
NCT02374567 Pharmacovigilance in Gerontopsychiatric Patients Recruiting Hannover Medical School Phase 3 The purpose of this multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment. The aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises. To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites. At Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed. Afterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system. In case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually. 2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Pipamperone

Condition Name

Condition Name for
Intervention Trials
Depression 2
Chronic Schizophrenia 1
Schizophrenia 1
Anxiety Disorders 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Depressive Disorder, Major 2
Depressive Disorder 2
Depression 2
Schizophrenia 2
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Clinical Trial Locations for Pipamperone

Trials by Country

Trials by Country for
Location Trials
United States 11
Canada 2
Germany 1
United Kingdom 1
Belgium 1
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Trials by US State

Trials by US State for
Location Trials
Washington 1
Texas 1
Pennsylvania 1
Ohio 1
New York 1
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Clinical Trial Progress for Pipamperone

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 2
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 3
Recruiting 1
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Clinical Trial Sponsors for Pipamperone

Sponsor Name

Sponsor Name for
Sponsor Trials
PharmaNeuroBoost N.V. 3
Hannover Medical School 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 3
Other 1
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