Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD) - Full Text View

Sponsor:	PharmaNeuroBoost N.V.
Information provided by:	PharmaNeuroBoost N.V.
ClinicalTrials.gov Identifier:	NCT00672659

Purpose

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:

Will increase the rate of resolution of symptoms with citalopram 40 mg.
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	Intervention	Phase
Depression	Drug: Citalopram + Pipamperone Drug: Citalopram	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate Pipamperone

U.S. FDA Resources

Further study details as provided by PharmaNeuroBoost N.V.:

Primary Outcome Measures:

Change in Montgomery-Asberg Depression Rating Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	165
Study Start Date:	February 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Placebo Comparator 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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672659

Locations

United Kingdom, Scotland
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

No publications provided

Responsible Party:	PharmaNeuroBoost N.V. ( Erik Buntinx, MD )
Study ID Numbers:	PNB/CPS 02 2007
Study First Received:	May 2, 2008
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00672659 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by PharmaNeuroBoost N.V.:

Lost of interest, Depressed Mood

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation

Dexetimide
Antidepressive Agents
Tranquilizing Agents
Pipamperone
Depression
Central Nervous System Depressants
Antipsychotic Agents
Depressive Disorder
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents

ClinicalTrials.gov processed this record on February 08, 2010