Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD)
Information source: PharmaNeuroBoost N.V.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Citalopram + Pipamperone (Drug); Citalopram (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: PharmaNeuroBoost N.V. Official(s) and/or principal investigator(s):
Erik Buntinx, MD, Study Chair, Affiliation: PharmaNeuroBoost N.V.
Alan Wade, MG, Study Director, Affiliation: CPSResearch
Gordon Crawford, MD, Principal Investigator, Affiliation: CPSResearch
Overall contact:
Gordon Crawford, MD, Phone: +44 141 946 7888, Email: gordon@cpsresearch.co.uk
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 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.
Clinical Details
Official title: Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Change in Montgomery-Asberg Depression Rating Scale score
Secondary outcome: The number of patients showing evidence of onset of action defined as a 20% improvement from baseline MADRS
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Gordon Crawford, MD, Phone: +44 141 946 7888, Email: gordon@cpsresearch.co.uk
CPSResearch, Glasgow, Scotland G20 0XA, United Kingdom; Recruiting
Gordon Crawford, MD, Phone: +44 141 946 7888, Email: gordon@cpsresearch.co.uk
Alan Wade, MD, Phone: +44 141 946 7888, Email: alangwade@fastmail.fm
Gordon Crawford, MD, Principal Investigator
Additional Information
Starting date: February 2008
Ending date: January 2009
Last updated: May 5, 2008
|
