Status:
COMPLETED
Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD)
Lead Sponsor:
PharmaNeuroBoost N.V.
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 m...
Eligibility Criteria
Inclusion
- Male and female patients
- 18-65 years inclusive
- 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
- Diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI) version 5.0.0.
- 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 at screen and baseline
- A non-psychotic state
- 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
Exclusion
- Premenopausal females not using adequate contraceptive measures
- Considered by the investigator to be a significant risk of suicide or scoring 5 or more on the MADRS question 10
- 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
- Significant physical illness which would interfere with trial assessments
- Reduced hepatic function
- Epilepsy
- History of cardiac dysrhythmia
- Alcohol intake above accepted UK ranges
- 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
- Resistant depression defined as having failed to respond to
- Two previous antidepressants at an adequate dose ingested for at least 4 weeks during the current episode
- To an augmentation therapy with an atypical antipsychotic drug
- Electroconvulsive therapy (ECT) for the current episode
- Formal psychotherapy or alternative treatments for one week prior to or during the study
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00672659
Start Date
February 1 2008
End Date
January 1 2009
Last Update
May 2 2011
Active Locations (1)
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1
CPSResearch
Glasgow, Scotland, United Kingdom, G20 0XA