Depression Clinical Trial
Official title:
Phase IIa Proof of Concept Study of 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:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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