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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672659
• Other study ID #: PNB/CPS 02 2007
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2008
• Last updated: April 29, 2011
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: April 2011
• Source: PharmaNeuroBoost N.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Citalopram + Pipamperone
Citalopram, 40 mg daily, 8 weeks Pipamperone, 5 mg twice daily, 8 weeks
• Citalopram
Citalopram, 40 mg daily, 8 weeks Placebo, dummy, twice a day, 8 weeks

Locations

Country	Name	City	State
United Kingdom	CPSResearch	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
PharmaNeuroBoost N.V.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery-Asberg Depression Rating Scale score		8 weeks	No
Secondary	The number of patients showing evidence of onset of action defined as a 20% improvement from baseline MADRS		At Weeks 1 and 2	No

External Links

•   Pubmed abstract