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

NCT00672659 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2011-05-02

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • PharmaNeuroBoost N.V.

    lead INDUSTRY

Principal Investigators

  • Erik Buntinx, MD · PharmaNeuroBoost N.V.

  • Alan Wade, MG · CPSResearch

  • Gordon Crawford, MD · CPSResearch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00672659 on ClinicalTrials.gov