Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD)
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:
- Will increase the rate of resolution of symptoms with citalopram 40 mg.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)|
- Change in Montgomery-Asberg Depression Rating Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- The number of patients showing evidence of onset of action defined as a 20% improvement from baseline MADRS [ Time Frame: At Weeks 1 and 2 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Citalopram, 40 mg daily in combination with Pipamperone, 5 mg twice daily (bd)
Drug: Citalopram + Pipamperone
Citalopram, 40 mg daily, 8 weeks Pipamperone, 5 mg twice daily, 8 weeks
Placebo Comparator: 2
Citalopram, 40 mg daily in combination with Placebo, dummy twice daily (bd)
Citalopram, 40 mg daily, 8 weeks Placebo, dummy, twice a day, 8 weeks
|Glasgow, Scotland, United Kingdom, G20 0XA|
|Study Chair:||Erik Buntinx, MD||PharmaNeuroBoost N.V.|
|Study Director:||Alan Wade, MG||CPSResearch|
|Principal Investigator:||Gordon Crawford, MD||CPSResearch|