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

Primary Purpose

Depression

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Citalopram + Pipamperone

Citalopram

About this trial

This is an interventional treatment trial for Depression focused on measuring Lost of interest, Depressed Mood

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CPSResearch

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Montgomery-Asberg Depression Rating Scale score

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00672659

First Posted

May 2, 2008

Last Updated

April 29, 2011

Sponsor

PharmaNeuroBoost N.V.

1. Study Identification

Unique Protocol Identification Number

NCT00672659

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

PharmaNeuroBoost N.V.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Lost of interest, Depressed Mood

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Citalopram + Pipamperone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Citalopram

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Montgomery-Asberg Depression Rating Scale score

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erik Buntinx, MD

Organizational Affiliation

PharmaNeuroBoost N.V.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Alan Wade, MG

Organizational Affiliation

CPSResearch

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Gordon Crawford, MD

Organizational Affiliation

CPSResearch

Official's Role

Principal Investigator

Facility Information:

Facility Name

CPSResearch

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G20 0XA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

21349239

Citation

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.

Results Reference

result

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/21349239

Description

Pubmed abstract

Learn more about this trial

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

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