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

NCT ID: NCT00672659

Last Updated: 2011-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Citalopram, 40 mg daily in combination with Pipamperone, 5 mg twice daily (bd)

Group Type: ACTIVE_COMPARATOR

Citalopram + Pipamperone

Intervention Type: DRUG

Citalopram, 40 mg daily, 8 weeks Pipamperone, 5 mg twice daily, 8 weeks

2

Citalopram, 40 mg daily in combination with Placebo, dummy twice daily (bd)

Group Type: PLACEBO_COMPARATOR

Citalopram

Intervention Type: DRUG

Citalopram, 40 mg daily, 8 weeks Placebo, dummy, twice a day, 8 weeks

Interventions

Citalopram + Pipamperone

Citalopram, 40 mg daily, 8 weeks Pipamperone, 5 mg twice daily, 8 weeks

Intervention Type: DRUG

Citalopram

Citalopram, 40 mg daily, 8 weeks Placebo, dummy, twice a day, 8 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female patients
• 18-65 years inclusive
• Suffering from a moderate to severe MDD as defined by DSM IV with an existence of depressed mood and loss of interest/anhedonia for at least four weeks and no longer than six months for the current episode
• Diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI) version 5.0.0.
• Clinical global impression - severity scale (CGI-S) rating of at least four and a minimum Hamilton Depression Scale (HAM-D) 17 items total score of 18 at screen and baseline
• A non-psychotic state
• Where appropriate, male patients should agree to use barrier contraceptive measures (condoms) during the course of the study and for three months after the last dose of medication

Exclusion Criteria

• Premenopausal females not using adequate contraceptive measures
• Considered by the investigator to be a significant risk of suicide or scoring 5 or more on the MADRS question 10
• Significant other psychiatric illness which would interfere with trial assessments - co-morbid generalised anxiety disorder (GAD) and panic disorder will be permitted where MDD is considered the primary diagnosis
• Significant physical illness which would interfere with trial assessments
• Reduced hepatic function
• Epilepsy
• History of cardiac dysrhythmia
• Alcohol intake above accepted UK ranges
• Recent (1 week) antidepressant (except for fluoxetine - 4 weeks and St John's Wort or MAOI's - 14 days), benzodiazepine or any other psychotropic medication ingestion including lithium or other mood stabilisers
• Resistant depression defined as having failed to respond to

• Two previous antidepressants at an adequate dose ingested for at least 4 weeks during the current episode
• To an augmentation therapy with an atypical antipsychotic drug
• Electroconvulsive therapy (ECT) for the current episode
• Formal psychotherapy or alternative treatments for one week prior to or during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaNeuroBoost N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

PharmaNeuroBoost N.V.

Principal Investigators

Erik Buntinx, MD

Role: STUDY_CHAIR

PharmaNeuroBoost N.V.

Alan Wade, MG

Role: STUDY_DIRECTOR

CPSResearch

Gordon Crawford, MD

Role: PRINCIPAL_INVESTIGATOR

CPSResearch

Locations

CPSResearch

Glasgow, Scotland, United Kingdom

Countries

United Kingdom

References

Wade AG, Crawford GM, Nemeroff CB, Schatzberg AF, Schlaepfer T, McConnachie A, Haazen L, Buntinx E. Citalopram plus low-dose pipamperone versus citalopram plus placebo in patients with major depressive disorder: an 8-week, double-blind, randomized study on magnitude and timing of clinical response. Psychol Med. 2011 Oct;41(10):2089-97. doi: 10.1017/S0033291711000158. Epub 2011 Feb 25.

Reference Type: RESULT

PMID: 21349239 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/21349239

Pubmed abstract

Other Identifiers

PNB/CPS 02 2007

Identifier Type: -

Identifier Source: org_study_id