Pipamperone/Citalopram (PipCit) versus Citalopram in the Treatment of Major Depressive disorder (MDD)

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: EUCTR2007-006127-12-GB
• Lead Sponsor: PharmaNeuroBoost N.V. (PNB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male and female patients.
2.18-65 years inclusive
3.Suffering from a moderate to severe MDD as defined by DSM IV with an existence of depressed mood and loss of interest/anhedonia for at least four weeks and no longer than six months for the current episode.
4.Diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI) version 5.0.0.
5.Clinical global impression - severity scale (CGI-S) rating of at least four and a minimum Hamilton Depression Scale (HAM-D) 17 items total score of 18 or more at baseline
6.A non-psychotic state.
7.Where appropriate, male patients should agree to use barrier contraceptive measures (condoms) during the course of the study and for three months after the last dose of medication

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Premenopausal females not using adequate contraceptive measures.
2.Pregnancy or lactation
3.Considered by the investigator to be a significant risk of suicide or scoring 5 or more on the MADRS question 10.
4.Significant other psychiatric illness which would interfere with trial assessments – co-morbid generalised anxiety disorder (GAD) and panic disorder will be permitted where MDD is considered the primary diagnosis.
5.Significant physical illness which would interfere with trial assessments
6.Reduced hepatic function (AST or ALT >3xUpper Limit of Normal)
7.Renal impairment (Creatinine .1.5x Upper Limit of Normal or Urea> 2x Upper Limit of Normal
8.Epilepsy
9.History of cardiac dysrhythmia
10.Alcohol intake above accepted UK ranges
11.Recent (1 week) antidepressant (except for fluoxetine – 4 weeks and St John’s Wort or MAOI’s – 14 days), benzodiazepine or any other psychotropic medication ingestion including lithium or other mood stabilisers.
12.Resistant depression defined as having failed to respond to
a.Two previous antidepressants at an adequate dose ingested for at least 4 weeks during the current episode.
b.To an augmentation therapy with an atypical antipsychotic drug.
13.Electroconvulsive therapy (ECT) for the current episode.
14.Formal psychotherapy or alternative treatments for one week prior to or during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate whether the addition of Pipamperone 5 mg twice daily (bd) to Citalopram, 40mg daily in patients suffering from MDD will improve the efficacy of citalopram 40mg in these patients.;Secondary Objective: To demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD:<br>1.Will increase the rate of resolution of symptoms with citalopram 40 mg.<br>2.Show the combined product to be safe and tolerable.<br>;Primary end point(s): The primary outcome measure will be the change in MADRS at Week 8.