Safety and Efficacy of Vilazodone in Major Depressive Disorder

• Register: EUCTR
• Last refreshed on: 16 November 2015
• Main ID: EUCTR2012-001950-25-BG
• Date of registration: 08/02/2013
• Prospective Registration: Yes
• Primary sponsor: Forest Research Institute, Inc., a wholly owned subsidiary of Forest Laboratories, Inc.
• Public title: Safety and Efficacy of Vilazodone in Major Depressive Disorder
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study with Vilazodone in Patients with Major Depressive Disorder
• Date of first enrolment: 13/06/2013
• Target sample size: 1500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001950-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Bulgaria, Czech Republic, Finland, Germany, Poland, Romania, Russian Federation, Serbia, Ukraine, United States

Contacts

• Name: Holly Roberts, MD
• Affiliation: Forest Research Institute, Inc., a wholly owned subsidiary of Forest Laboratories, Inc.

• Name: Holly Roberts, MD
• Affiliation: Forest Research Institute, Inc., a wholly owned subsidiary of Forest Laboratories, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
Criteria to be Assessed at Visit 1 (Screening):
1. Provide written informed consent before the initiation of any study-specific procedures.
2. Be a male or female outpatient, 18 to 70 years of age, inclusive.
3. Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD (American Psychiatric Association, 2000), confirmed with the Mini International Neuropsychiatric Interview (MINI), with an ongoing major depressive episode of = 8 weeks and = 18 months in duration at Visit 1 (Screening). Patients must have a minimum of 3 lifetime episodes of MDD, (including the current episode) and 2 episodes within the past 5 years (including the current episode).
4. Have a score of = 26 on the Montgomery-Åsberg Depression Rating Scale (MÅDRS).
5. Have a body mass index between 18 and 40, inclusive.
6. If female of childbearing potential, have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test.
7. Have normal physical examination findings, clinical laboratory test results, and electrocardiogram (ECG) results from Screening (Visit 1), or abnormal results that are judged not clinically significant by the Investigator and documented as such in the eCRF.

Criteria to be Assessed at Visit 2 (Baseline):
8. Have a score of = 26 on the MÅDRS.
9. Negative results for illegal or prohibited substances or alcohol on a urine drug screen.

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 1290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210

Exclusion criteria:
•Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control
•Patients with a history of meeting DSM-IV-TR criteria for:

?any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode;
?any depressive episode with psychotic or catatonic features;
?panic disorder with or without agoraphobia;
?obsessive-compulsive disorder;
?Schizophrenia, schizoaffective, or other psychotic disorder;
?bulimia or anorexia nervosa within the past 5 years;
?presence of borderline personality disorder or antisocial personality disorder; mental retardation, dementia, amnesia, or other cognitive disorders
•Patients who are considered a suicide risk



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Major Depressive Disorder
MedDRA version: 16.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873
MedDRA version: 16.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 100000004873
MedDRA version: 16.1 Level: LLT Classification code 10067465 Term: Major depressive disorder aggravated System Organ Class: 100000004873
MedDRA version: 16.1 Level: LLT Classification code 10053708 Term: Major depressive disorder with melancholic features System Organ Class: 100000004873

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention(s)

Trade Name: Viibryd ®
Product Name: vilazodone hydrochloride
Pharmaceutical Form: Tablet
INN or Proposed INN: Vilazodone hydrochloride
CAS Number: 163521-08-2
Current Sponsor code: Vilazodone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Viibryd ®
Product Name: vilazodone hydrochloride
Pharmaceutical Form: Tablet
INN or Proposed INN: Vilazodone Hydrochloride
CAS Number: 163521-08-2
Current Sponsor code: Vilazodone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Primary end point(s): Time to first relapse during the double-blind treatment phase, defined as the number of days from the randomization date to the relapse date.

Secondary Objective: Not applicable.

Timepoint(s) of evaluation of this end point: Relapse during the DBP will be defined as meeting any one or more of the following criteria:
• MÅDRS score of = 18 and MDE per MDD checklist
• MÅDRS total score = 18 at 2 consecutive visits (Second visit to be scheduled in 7 - 14 day period after the first visit).
• Discontinuation for insufficient therapeutic response during the DBP as indicated in the termination page of the eCRF.

The evaluation of endpoint is therefore ongoing during the conduct of the study.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable.

Secondary end point(s): Not applicable.

Secondary ID(s)

NCT01573598

VLZ-MD-02

2012-001950-25-DE

Source(s) of Monetary Support

Forest Research Institute, Inc., a wholly owned subsidiary of Forest Laboratories, Inc.