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Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT00683592
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : October 27, 2010
Last Update Posted : October 27, 2010
Sponsor:
Information provided by:
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE May 21, 2008
First Posted Date  ICMJE May 23, 2008
Results First Submitted Date  ICMJE July 19, 2010
Results First Posted Date  ICMJE October 27, 2010
Last Update Posted Date October 27, 2010
Study Start Date  ICMJE March 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2010)
Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score. [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 ]
The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression. The scale was constructed to be sensitive to treatment effects. The change from baseline in MADRS total score has a possible range of -60 to 60 where negative values reflect improvement in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2008)
MADRS [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT00683592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2010)
  • Change From Baseline to Week 8 in the HAM-D 17 (17-Item Hamilton Rating Scale for Depression) Total Score [ Time Frame: Baseline, week 1, week 2, week 4, week 6, week 8 ]
    The HAM-D 17 is a 17-item subscale of the HAM-D 21, which is designed to be completed by a trained rater. It is designed for rating depressive symptom severity in patients with a confirmed diagnosis of depressive disorder. The change in HAM-D 17 has a possible range of -52 to 52 with negative values indicating improvment in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.
  • The CGI-I (Clinician's Global Impression of Improvement) Score at Week 8 [ Time Frame: Week 1, Week 2, Week 4, Week 6, Week 8 ]
    The CGI-I scale measures change from the baseline state at every visit after the baseline visit. It permits a global evaluation of the patient's improvement over time. At the scheduled clinic visits, the clinician assessed the patient's improvement relative to the symptoms at baseline on a CGI-I item using a 7-point scale, where 1 = very much improved and 7 = very much worse. The method of last observation carried forward was utilized for subjects who discontinued prematurely.
  • Change From Baseline to Week 8 in the HAM-A ( Hamilton Anxiety Rating Scale) Total Score [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 ]
    The HAM-A is a rating scale developed to quantify the severity of anxiety. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Change from baseline in the HAM-A total score may range from -52 to 52 with negative value indicating improvement in anxiety symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.
  • MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate at Week 8 [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 ]
    MADRS response was defined as ≥ 50% decrease from baseline in MADRS total score at Week 8. The response rate is the percentage of subjects in each treatment group meeting the criteria for response. The method of last observation carrier forward was utilized for subjects who discontinued prematurely.
  • MADRS (Montgomery-Asberg Depression Rating Scale) Remission Rate at Week 8 [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 ]
    MADRS remission was defined as a MADRS total score < 10 at Week 8. The remission rate is the percentage of subjects in each treatment group who met the criteria for remission. The method of last observation carried forward was utilized for subjects who discontinued prematurely.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2008)
  • HAM-D [ Time Frame: 8 weeks ]
  • CGI [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)
Official Title  ICMJE A Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Safety of Vilazodone 40 mg qd and Evaluating Genetic Biomarkers Associated With Treatment Response in Patients With Major Depressive Disorder (MDD)
Brief Summary This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria.
Detailed Description This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. This study will enroll approximately 470 patients at approximately 10 clinical sites. Safety and efficacy will be assessed at each visit. A DNA sample will be collected and analyzed for response to vilazodone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: vilazodone
    titration to 40 mg tablets qd (once a day) for 8 weeks
    Other Name: EMD68843, SB-659746
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: 1
    vilazodone
    Intervention: Drug: vilazodone
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2010)
481
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2008)
470
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients 18-70 years of age.
  • A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR (296.2/296.3) with a current Major Depressive Episode of less than two year's duration with a minimum duration of at least 4 weeks.
  • Meets DSM-IV-TR criteria for Major Depressive Disorder.
  • HAM-D score ≥ 22 on the first 17 items of the 21-item HAM-D.
  • HAM-D item 1 (depressed mood) score ≥ 2.
  • Patients must be able to provide written informed consent
  • Patients must be able to speak, read and understand English

Exclusion Criteria:

  • Patients with a current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder.
  • Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
  • Patients who meet DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to the Screening Visit or substance dependence within 6 months prior to the Screening Visit.
  • Patients who meet criteria for any of the following DSM-IV-TR MDD Specifiers: [a] With Catatonic Features; [b] With Postpartum Onset; [c] With Seasonal Pattern [d]severe with Psychotic Features.
  • Patients who are receiving formal psychotherapy or have had psychotherapy within the 12 weeks prior to the Screening Visit.
  • Patients who have any one of the following:

    • In the month prior to screening, have had active suicidal ideation with some intent to act, without specific plan.
    • In the month prior to screening, have had suicidal ideation with specific plan and intent.
    • Have made a suicide attempt within the 6 months prior to the screening visit.
    • In the opinion of the Investigator, is currently at significant risk of suicide.
  • Patients who have had an inadequate response to at least 2 consecutive antidepressants from different classes given at adequate doses for an adequate duration.
  • Patients who have received electroconvulsive therapy within the 6 months prior to the Screening Visit.
  • Patients currently taking a psychotropic drug. Patients who have taken psychotropic drugs must have discontinued these prior to the Screening Visit. The minimum discontinuation periods are outlined in the study protocol.
  • Patients taking migraine medications with a serotonergic mechanism of action
  • Patients taking CYP3A4 inhibitors such as grapefruit juice, ketoconazole, diltiazem, and macrolide antibiotics or montelukast
  • Patients with known hypersensitivity to SSRIs (selective serotonin reyptake inhibitors) or 5-HT1a agonists.
  • Patients previously treated with vilazodone (also known as SB-659746-A or EMD 68 843).
  • Patients with a history of clinically significant cardiac, renal, neurologic, cerebrovascular, hepatic, hematologic, metabolic or pulmonary disorders.
  • Patients with any serious medical disorder or condition that would, in the investigator's opinion, preclude the administration of study medication.
  • Female patients must not be pregnant, lactating, or planning to become pregnant during the time of study participation. All female patients must be at least 1 year post menopausal or irreversibly surgically sterilized (by hysterectomy, oophorectomy, or bilateral tubal ligation with resection) or determined not to be at risk of pregnancy.
  • Patients with clinically significant abnormalities on electrocardiogram.
  • Patients having clinically significant abnormal laboratory findings.
  • Patients with a positive drug screen.
  • Patients who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
  • Patients that have taken an investigational drug or participated in an investigational drug trial within the past 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00683592
Other Study ID Numbers  ICMJE CLDA-07-DP-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carol R. Reed, MD, PGxHealth, LLC
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carol R Reed, MD Forest Laboratories
PRS Account Forest Laboratories
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP