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

This study has been completed.
Sponsor:
Information provided by:
PharmaNeuroBoost N.V.
ClinicalTrials.gov Identifier:
NCT00672659
First received: May 2, 2008
Last updated: April 29, 2011
Last verified: April 2011

May 2, 2008
April 29, 2011
February 2008
January 2009   (final data collection date for primary outcome measure)
Change in Montgomery-Asberg Depression Rating Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00672659 on ClinicalTrials.gov Archive Site
The number of patients showing evidence of onset of action defined as a 20% improvement from baseline MADRS [ Time Frame: At Weeks 1 and 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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
  • Active Comparator: 1
    Citalopram, 40 mg daily in combination with Pipamperone, 5 mg twice daily (bd)
    Intervention: Drug: Citalopram + Pipamperone
  • Placebo Comparator: 2
    Citalopram, 40 mg daily in combination with Placebo, dummy twice daily (bd)
    Intervention: Drug: Citalopram
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00672659
PNB/CPS 02 2007
Yes
Erik Buntinx, MD, PharmaNeuroBoost N.V.
PharmaNeuroBoost N.V.
Not Provided
Study Chair: Erik Buntinx, MD PharmaNeuroBoost N.V.
Study Director: Alan Wade, MG CPSResearch
Principal Investigator: Gordon Crawford, MD CPSResearch
PharmaNeuroBoost N.V.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP