Major Depressive Disorder MedDRA version: 17.0 Level: LLT Classification code 10025458 Term: Major depressive disorder, recurrent episode, moderate degree System Organ Class: 100000004873
Conditions
Interventions
Product Name: Viotra 70mg extended release tablets (encapsulated)
Pharmaceutical Form: Capsule
INN or Proposed INN: Tramadol
CAS Number: 36282-47-0
Concentration unit: mg milligram(s)
Concentration t
Sponsors
e-Therapeutics plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent. 2. Male or female. 3. Age 18-65 years inclusive. 4. Subjects with a current episode of moderate to severe Major Depressive Disorder meeting the criteria of 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. 5. 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 randomisation. 6. 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. The following contraceptive methods are acceptable: hormonal (e.g. oral, injection, transdermal patch, implant, cervical ring), barrier (e.g. condom or diaphragm with spermicidal agent), intrauterine system (IUS) or intrauterine device (IUD). If hormonal contraceptives are used by female subjects they must be established for 6 weeks before the first administration of test product. Male sterilisation is considered an acceptable form of contraception if the appropriate post-vasectomy documentation (absence of sperm) is provided. Sexual abstinence is considered acceptable if this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. To be considered „not of child-bearing potential “ female subjects must be surgically sterilized or post-menopausal (defined as no menses for one year or an FSH value >40 IU/L). Male subjects with female partners of child-bearing potential must use an acceptable method of contraception throughout the study and for 30 days after. 7. Able to understand and comply with the requirements of the study as judged by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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. 3. Significant physical illness which would interfere with trial assessments. 4. Recent (within 1 week of screening) antidepressants (except for fluoxetine [within 4 weeks of screening] and St John’s Wort or MAOI’s [within 14 days of screening]). 5. Benzodiazepine or any other psychotropic medication including lithium or other mood stabilisers within 1 week of screening. Propranolol is permitted where a stable dose (minimum 30 days) has been prescribed for non-psychotropic reasons e.g. high blood pressure. 6. Oral anticoagulant therapy within one month of screening. 7. Formal psychotherapy or alternative treatments for one week prior to screening or during the study defined as that administered by a specialist healthcare professional, using formal structured techniques. 8. Reduced hepatic function defined as liver enzyme levels =2.5 times upper limit of normal. 9. Renal insufficiency defined as creatinine clearance 470ms for female subjects of >450ms for male subjects, calculated using the QTcB correction formula, or second degree or higher heart block on an ECG recording, at screening. 21. Allergy to the study drugs or excipients. 22. Treatment with another investigational medicinal product within the 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The mean difference in baseline-adjusted MADRS score at the end of treatment (week 8).;Timepoint(s) of evaluation of this end point: End of 8 weeks.;Main Objective: To demonstrate that the antidepressant activity of Viotra™ is not inferior to amitriptyline in subjects who have an unsatisfactory response to / are resistant to treatment with SSRIs.;Secondary Objective: To evaluate the safety and tolerability of Viotra™. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The mean difference in baseline-adjusted MADRS score at weeks 1, 2, 4 and 6. • Percentage of subjects with remission defined as = 10 on the MADRS at the end of treatment (week 8). • Percentage of responders defined as = 50% decrease from baseline in the MADRS at the end of treatment (week 8). • The mean difference in baseline-adjusted CGI severity at week 8. • The mean difference in CGI improvement at weeks 1, 2, 4, 6, and 8.;Timepoint(s) of evaluation of this end point: Weeks 1, 2, 4, 6, and 8. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials Information
e-Therapeutics plc
Outcome results
None listed