Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD)
|ClinicalTrials.gov Identifier: NCT00672659|
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : May 2, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Citalopram + Pipamperone Drug: Citalopram||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
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
- Change in Montgomery-Asberg Depression Rating Scale score [ Time Frame: 8 weeks ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672659
|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|