Trial | NCT00672659  Report issue

Title

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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    165
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.
Study Started
Feb 29
2008
Primary Completion
Jan 31
2009
Study Completion
Jan 31
2009
Last Update
May 02
2011
Estimate

Drug Citalopram + Pipamperone

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

Drug Citalopram

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

1 Active Comparator

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

2 Placebo Comparator

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

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
No Results Posted