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

NCT02014363 | Completed Phase 2 Results

• 2 other identifiers: ETS6103-0032013-000719-26
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Baseline-adjusted (Montgomery-Asberg Depression Scale) MADRS Score at the End of Treatment.

  The mean difference in baseline-adjusted MADRS score at the end of treatment in the per protocol population using the last observation carried forward (LOCF) method. MADRS is used to assess the range of symptoms that are most frequently observed in patients with major depression. The MADRS test includes 10 items and uses a 0 to 6 severity scale, with higher scores indicating increasing depressive symptoms. The total MADRS score is derived by adding all the scores from the 10 items, meaning the lowest possible score is 0 and the highest possible is 60.

  Baseline (start of randomized treatment) and 8 weeks post start of treatment

Study Arms (4)

ETS6103 (low dose)

EXPERIMENTAL

ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).

Drug: ETS6103 (low dose)

ETS6103 (high dose)

EXPERIMENTAL

ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).

Drug: ETS6103 (high dose)

Amitriptyline

ACTIVE COMPARATOR

Amitriptyline tablets (encapsulated) Standard dosing regime

Drug: Amitriptyline

Lead-in phase

NO INTERVENTION

Citalopram tablets: Standard dosing regime

Interventions

ETS6103 (low dose) DRUG

ETS6103 (low dose)

ETS6103 (high dose) DRUG

ETS6103 (high dose)

Amitriptyline DRUG

Amitriptyline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• e-Therapeutics PLC: lead

Study Sites (1)

CPS Research

Glasgow, Scotland, G20 OXA, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Operations Manager
• Organization: e-Therapeutics plc

contact@etherapeutics.co.uk

+44 1993 880000

Study Officials

• Alan G Wade, MBChb

  CPS Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 11, 2017
• Results First Posted: January 11, 2017

Record last verified: 2016-11

Locations

GB (1)