A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00644358
First received: March 20, 2008
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD. This study will enroll approximately 600 patients.


Condition Intervention Phase
Major Depressive Disorder
Drug: vilazodone
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • adverse events (AEs), laboratory parameters, physical examinations, vital signs, weight, ECGs, the CSFQ, ophthalmologic exams, the Columbia-Suicide Severity Rating Scale (C-SSRS). [ Time Frame: adverse events (AEs), laboratory parameters, physical examinations, vital signs, weight, ECGs, the CSFQ, and C-SSRs at every visit. Ophthalmologic exams at study entry, 6 months, and End of Treatment. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The study will collect information on effectiveness of vilazodone therapy over the course of the treatment period using MADRS, CGI severity of illness and CGI improvement scales. [ Time Frame: Efficacy scales are admistered at every visit. ] [ Designated as safety issue: No ]

Enrollment: 616
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
vilazodone
Drug: vilazodone
titration to 40mg qd for 1 year
Other Name: EMD 68843, SB-659746

Detailed Description:

Patients will be enrolled at approximately 40 US investigative sites and receive vilazodone for 52 weeks of open label treatment. Safety measurements will include adverse events, vital signs, laboratory, ophthalmologic exams, Changes in Sexual Function Questionnaire (CSFQ) scale and ECG findings collected over the course of the treatment period. Effectiveness measurements will be done at baseline and each visit until week 52 or end-of-treatment. A DNA sample will be collected for genetic analysis related to response to vilazodone.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females 18-70 years of age.
  • Meets DSM-IV-TR criteria for Major Depressive Disorder.
  • HAM-D score ≥ 18 on the first 17 items of the 21-item HAM-D at Screening and Baseline Visits.
  • Patients must have general ocular health.

Exclusion Criteria:

  • 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 or dependence within 1 year of the Baseline visit.
  • Patients who, in the Investigator's judgment, pose a serious suicidal or homicidal risk or have made a suicide attempt within 6 months prior to Screening Visit.
  • Patients who are taking psychotropic drugs. Patients who have taken psychotropic drugs must have discontinued these prior to Screening Visit.
  • Patients taking migraine medications with a serotonergic mechanism of action.
  • Patients taking CYP3A4 inhibitors such as grapefruit juice, ketoconazole, diltiazem, and macrolide antibiotics.
  • Patients with a known hypersensitivity to SSRIs or 5-HT1a agonists.
  • Patients previously treated with vilazodone.
  • Patients taking Chantix or St. John's Wort.
  • Presence of significant acute or chronic medical disorders by history or physical exam.
  • Patients with a history of seizure disorders.
  • Prior history of malignancy if patient has < 5 yr survival OR completed treatment <1yr prior to enrollment and is currently without evidence of recurrence.
  • Skin cancers other than malignant melanoma will be permitted.
  • Patients with evidence of other central nervous system disorders including psychosis, delirium, dementia and amnesic disorders.
  • Patients with renal impairment or hepatic impairment.
  • Patients who are not euthyroid.
  • Patients with any serious medical or neurological disorder or condition that make it unlikely that the patient could complete one year of treatment or would otherwise preclude the administration of study medication.
  • Female patients must not be pregnant, not lactating, and not planning to become pregnant during the time of study participation. All female patients who are not at least 1 year post menopausal or irreversibly surgically sterilized must be using adequate and reliable contraception throughout the trial.
  • Patients with clinically significant ECG abnormalities which, as determined by the investigator, make it unlikely that the patient would complete one year of treatment or would otherwise preclude treatment with vilazodone.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644358

  Show 38 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Carol R Reed, MD Forest Laboratories
  More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00644358     History of Changes
Other Study ID Numbers: CLDA-07-DP-04
Study First Received: March 20, 2008
Last Updated: September 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 28, 2014