NCT00672659

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

Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: PharmaNeuroBoost N.V. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Citalopram + Pipamperone	Citalopram, 40 mg daily, 8 weeks Pipamperone, 5 mg twice daily, 8 weeks
DRUG	Citalopram	Citalopram, 40 mg daily, 8 weeks Placebo, dummy, twice a day, 8 weeks

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-05-06
• Last updated: 2011-05-02

Locations

1 site across 1 country: United Kingdom