drugset / Trial / NCT00672659

Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD)

NCT00672659

Phase 2 Completed 165 enrolled PharmaNeuroBoost N.V.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-02
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Citalopram Small molecule 40 mg
Comparator Pipamperone Small molecule 5 mg