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

NCT00672659 | Completed Phase 2 DMC

• 1 other identifier: PNB/CPS 02 2007
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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. 1.Will increase the rate of resolution of symptoms with citalopram 40 mg.
2. 2.Show the combined product to be safe and tolerable.

Conditions

Depression

Keywords

Lost of interest, Depressed Mood

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale score

  8 weeks

Secondary Outcomes (1)

• The number of patients showing evidence of onset of action defined as a 20% improvement from baseline MADRS

  At Weeks 1 and 2

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Citalopram + Pipamperone

2

PLACEBO COMPARATOR

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

Drug: Citalopram

Interventions

Citalopram + Pipamperone DRUG

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

1

Citalopram DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PharmaNeuroBoost N.V.: lead

Study Sites (1)

CPSResearch

Glasgow, Scotland, G20 0XA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21349239 RESULT

Related Links

• Pubmed abstract

MeSH Terms

Conditions

Depression; Consciousness Disorders

Interventions

Citalopram; pipamperone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Erik Buntinx, MD

  PharmaNeuroBoost N.V.

  STUDY CHAIR

• Alan Wade, MG

  CPSResearch

  STUDY DIRECTOR

• Gordon Crawford, MD

  CPSResearch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 2, 2011

Record last verified: 2011-04

Locations

GB (1)