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

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01312922

Run by

PharmaNeuroBoost N.V.

People needed

555

Starts

2011-09-01

Expected to finish

2012-12-01

Last updated by the study team

2022-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
• Patient understands the investigational nature of the trial and is willing and able to comply with the trial requirements.
• Patient is male or female, aged ≥ 18 years.
• Patient has MDD according to the DSM IV-R criteria with an existence of depressed mood (DSM-IV-R Crit. A1) and loss of interest/anhedonia (DSM-IV-R Crit. A2) as confirmed by the MINI, lasting for at least 4 weeks and no longer than 18 months (78 weeks) for the current episode, and causing significant functional impairment (DSM-IV-R MDD C- criterion).
• CGI-S rating of at least 4 and a minimum MADRS total score of 26 using IVRS ePRO at Baseline.

You may not qualify if…

• Patient is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or who does not consistently use 2 combined effective methods of contraception (including at least 1 barrier method), unless sexually abstinent.
• Existence of Mood Disorder with psychotic features and/or high suicidality risk, as confirmed by MINI.
• Concomitant diagnosis of any additional primary Axis I disorder and presence of any of the following co-morbid disorders: (Hypo)manic episode, Panic Disorder (limited symptom attacks allowed), Obsessive Compulsive Disorder, Post-traumatic Stress Disorder, Alcohol dependence, any other Substance abuse and/or dependence, Psychotic Disorder, Eating Disorder, or General Anxiety Disorder, as confirmed by MINI.
• Concomitant diagnosis of any primary Axis II disorder.
• Patient is hospitalized.
• Patient has a clinically relevant renal dysfunction (e.g. GFR <60mL/min).
• Patient has hepatic dysfunction (total bilirubin >2.0mg/dL or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 2 times the upper limit of the reference range).
• Patient has a malignant neoplastic disease, a documented history of epilepsy (juvenile convulsions excepted) or a documented, in the opinion of the investigator, clinically relevant risk of bleeding (eg. severe bleeding disorder, treatment with warfarin, …).
• Patient with a documented history or concomitant diagnosis or significant risk of cardiac arrhythmia or dysrhythmia, including a QTc interval of ≥500 ms at Baseline.
• Patient has any other medical or psychiatric condition, which in the opinion of the investigator, can jeopardize or would compromise the patient's ability to participate in this trial or that would interfere with trial assessments.
• Patient with documented alcohol or drug abuse, or having a positive standard screen for alcohol or drugs (including benzodiazepines and opioids).
• Patient received, in the past 7 days treatment with any psychoactive drug prior to randomization, including typical and atypical antipsychotics, hypnotics, antidepressants, anxiolytic drugs, anticonvulsive therapy, opioids, monoamine oxidase (MAO) inhibitors, sedative antihistamines, psychostimulants or amphetamines, dopamine D2 receptor antagonists, butyrophenones, metoclopramide, lithium, anticonvulsants, benzodiazepines, or barbiturates. If patient has received such therapy, a washout period of at least 7 days prior to baseline is required before inclusion in this trial (except fluoxetine: 4 weeks, and St John's Wort or MAO inhibitors: within 2 weeks).
• Concomitant treatment with diuretics, QT prolongation drugs, or dopamine agonists.
• Resistant depression defined as having failed to respond to either: a/ 2 previous antidepressants at an adequate dose administered for at least 4 weeks during the current episode; b/ augmentation therapy with any atypical antipsychotic drug
• Electroconvulsive therapy (ECT) or repetitive Transcranial Magnetic Stimulation therapy (rTMS) within the last 6 months; Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS) ever.
• Formal psychotherapy or alternative treatment for 1 week prior to or during the study.
• Patient has participated in another trial of an investigational agent (including medical device) within the last 3 months prior to baseline or is currently participating in another trial of an investigational drug.
• Known hypersensitivity to any of the study drugs

Where it is running

• 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

Full record on ClinicalTrials.gov

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