Safety and Efficacy Study Comparing ETS6103 With Amitriptyline in the Treatment of Major Depressive Disorder (MDD)

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate that the antidepressant activity of ETS6103 is not inferior to amitriptyline in subjects who have an unsatisfactory response to / are resistant to treatment with SSRIs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: e-Therapeutics PLC
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Serotonin Uptake Inhibitors

Criteria

Inclusion Criteria:

• Signed informed consent

• Male or female

• Age 18-65 years inclusive

• Subjects with a current episode of moderate to severe Major Depressive Disorder meeting the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM) IV -TR and documented using the brief structured interview Mini International Neuropsychiatric Interview (MINI) version 5.0 and with a minimum duration of two weeks and a maximum of twelve months

• Minimum Hamilton Depression Scale (HAM-D) 17 items total score of 18 at screening and ≥12 at the end of the lead-in phase prior to randomization.

• Female subjects of childbearing potential must have a negative pregnancy test at the Screening Visit and must use an acceptable method of contraception throughout the study and for 30 days after. Male subjects with female partners of child-bearing potential must use an acceptable method of contraception throughout the study and for 30 days after.

• Able to understand and comply with the requirements of the study as judged by the investigator

Exclusion Criteria:

• Considered by the investigator to be at significant risk of suicide or scoring 5 or more on the Montgomery Asberg Depression Rating Scale (c) question 10

• Significant other psychiatric illness which would interfere with trial assessments co-morbid generalized 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

• Recent (within 1 week of screening) antidepressants (except for fluoxetine [within 4 weeks of screening] and St John's Wort or Monoamine oxidase inhibitors (MAOI) [within 14 days of screening]),

• Benzodiazepine or any other psychotropic medication including lithium or other mood stabilizers within 1 week of screening

• Oral anticoagulant therapy within one month of screening

• Formal psychotherapy or alternative treatments for one week prior to screening or during the study

• Reduced hepatic function defined as liver enzyme levels ≥2.5 times upper limit of normal

• Renal insufficiency defined as creatinine clearance <30 mL/min

• Epilepsy

• Uncontrolled hypothyroidism

• Uncontrolled hypertension

• Acute porphyria

• Urinary retention, prostatic hypertrophy, narrow angle glaucoma or increased intraocular pressure or any other clinically relevant contraindication stated in the Summary of Product Characteristics (SmPC) for citalopram, tramadol or amitriptyline

• History of significant cardiac dysrhythmia or history of myocardial infarction within 1 year prior to screening

• Significant history of alcohol or substance abuse

• Regular alcohol intake above the recommended United Kingdom (UK) guideline of 4 units per day for males or 3 units per day for females

• Pregnant or lactating women

• Known hepatitis B or C or human immunodeficiency virus (HIV) or syphilis seropositivity.

• A corrected QT interval of >470ms for female subjects of >450ms for male subjects, calculated using the QTcB (Bazett Correction Formula) , or second degree or higher heart block on an electrocardiography (ECG) recording, at screening.

• Allergy to the study drugs or excipients

• Treatment with another investigational medicinal product within the 30 days prior to screening.