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CompletedNCT00672659Updated May 2, 2011

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

A Phase 2 interventional study of Citalopram + Pipamperone and Citalopram in Depression, sponsored by PharmaNeuroBoost N.V.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-05-02.

Sponsored by PharmaNeuroBoost N.V. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Depression

Keywords

  • Lost of interest, Depressed Mood
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 165 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

PharmaNeuroBoost N.V. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
165 participants (actual)

Study arms

  • Active comparator
    1

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

    Drug: Citalopram + Pipamperone

  • Placebo comparator
    2

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

    Drug: Citalopram

Interventions

  • DrugCitalopram + Pipamperone

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

  • DrugCitalopram

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

06

What researchers measure

Primary outcomes

  1. Change in Montgomery-Asberg Depression Rating Scale score

    Time frame: 8 weeks

Secondary outcomes

  1. 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

07

Study locations

1 site
  • CPSResearch
    Glasgow, Scotland G20 0XA, United Kingdom
08

References and documents

Publications

  • 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. PubMed 21349239 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00672659
Lead sponsor
PharmaNeuroBoost N.V.
First posted
May 6, 2008
Start date
Feb 2008
Primary completion
Jan 2009
Completion
Jan 2009
Last update
May 2, 2011

Study contacts

Erik Buntinx, MD
study chair · PharmaNeuroBoost N.V.
Alan Wade, MG
study director · CPSResearch
Gordon Crawford, MD
principal investigator · CPSResearch

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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