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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: Citalopram + Pipamperone; Drug: Citalopram

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Montgomery-Asberg Depression Rating Scale score	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of patients showing evidence of onset of action defined as a 20% improvement from baseline MADRS	At Weeks 1 and 2

Collaborators and Investigators

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

Publications and helpful links

General 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.

Helpful Links

• Pubmed abstract

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: May 2, 2008
• First Submitted That Met QC Criteria: May 5, 2008
• First Posted (Estimate): May 6, 2008

Study Record Updates

• Last Update Posted (Estimate): May 2, 2011
• Last Update Submitted That Met QC Criteria: April 29, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Lost of interest, Depressed Mood
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin Antagonists; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Dexetimide; Pipamperone
• Other Study ID Numbers: PNB/CPS 02 2007