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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Depression	Drug: Citalopram + Pipamperone; Drug: Citalopram	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	165 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)
Study Start Date :	February 2008
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	January 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 1; Citalopram, 40 mg daily in combination with Pipamperone, 5 mg twice daily (bd)	Drug: Citalopram + Pipamperone; Citalopram, 40 mg daily, 8 weeks Pipamperone, 5 mg twice daily, 8 weeks
Placebo Comparator: 2; Citalopram, 40 mg daily in combination with Placebo, dummy twice daily (bd)	Drug: Citalopram; Citalopram, 40 mg daily, 8 weeks Placebo, dummy, twice a day, 8 weeks

Outcome Measures

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Primary Outcome Measures :

1. Change in Montgomery-Asberg Depression Rating Scale score [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United Kingdom
CPSResearch
Glasgow, Scotland, United Kingdom, G20 0XA

Sponsors and Collaborators

PharmaNeuroBoost N.V.

Investigators

Study Chair:	Erik Buntinx, MD	PharmaNeuroBoost N.V.
Study Director:	Alan Wade, MG	CPSResearch
Principal Investigator:	Gordon Crawford, MD	CPSResearch

More Information

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Additional Information:

Pubmed abstract 

Publications of Results:

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.

Responsible Party:	Erik Buntinx, MD, PharmaNeuroBoost N.V.
ClinicalTrials.gov Identifier:	NCT00672659 History of Changes
Other Study ID Numbers:	PNB/CPS 02 2007
First Posted:	May 6, 2008
Last Update Posted:	May 2, 2011
Last Verified:	April 2011

Keywords provided by PharmaNeuroBoost N.V.:

Lost of interest, Depressed Mood

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms; Citalopram; Dexetimide; Pipamperone; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents	Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Serotonin Antagonists; Antipsychotic Agents; Tranquilizing Agents