Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
PharmaNeuroBoost N.V.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be 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
