Skip to main content
OpenTrials
Completed

NCT Number: NCT00672659

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CPSResearch

Glasgow, Scotland, G20 0XA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citalopram + Pipamperone

Drug

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

Citalopram

Drug

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

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

Sponsors and collaborators

Lead sponsor

PharmaNeuroBoost N.V.

Industry

Registry information

Official study title

Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 6, 2008
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.