Double-Blind Treatment of Major Depressive Disorder With Vilazodone

NCT01742832 | Completed Phase 2 Results DMC

• 1 other identifier: 2012MDDVilaz
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of vilazodone for the treatment of major depressive disorder versus citalopram. Doctors want to determine if vilazodone is effective for the treatment of major depressive disorder in those who have not responded to generic selective serotonin reuptake inhibitors (SSRI), which is a class of anti-depressant drugs such as Prozac, Lexapro, Paxil, or Zoloft. Both vilazodone and citalopram have been approved for the treatment of major depressive disorder. This research is being done because the researchers want to find out if vilazodone works in reducing the symptoms of depression significantly more than a generic SSRI.

Conditions

Major Depressive Disorder

Keywords

Vilazodone; Citalopram; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included. MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used.

  Baseline and final MADRS scores during the double-blind phase.

Study Arms (2)

Vilazodone

ACTIVE COMPARATOR

A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

Drug: Vilazodone

Citalopram

PLACEBO COMPARATOR

For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

Drug: Citalopram

Interventions

Vilazodone DRUG

A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

Vilazodone

Citalopram DRUG

For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

Citalopram

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women age 18-60;
• Primary diagnosis of MDD. Diagnosis of MDD will be made with the Structured Clinical Interview for DSM-IV
• Score of at least 23 on the Montgomery-Åsberg Depression Rating Scale
• Treatment with citalopram at a dose no higher than 20mg/day for no longer than 4 weeks (subjects not currently taking an antidepressant will be started on citalopram 20mg/day for the 6-week open-label phase)
• Ability to understand and sign the consent form.

You may not qualify if:

• Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination (e.g., congestive heart failure, bradyarrhythmias).
• Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
• Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS)
• Past 3-month DSM-IV substance abuse or dependence
• Illegal substance use based on urine toxicology screening
• Initiation of psychotherapy or behavior therapy specifically for MDD from a mental health professional within 3 months prior to study baseline
• Concomitant use of any antidepressant (except low dose doxepin, amitriptyline, trazodone when used PRN as a hypnotic).
• Concomitant use of medications that prolong the QT interval or are CYP2C19 inhibitors (e.g., cimetidine)
• Previous treatment with vilazodone
• Diagnosis of bipolar I or II disorder or any psychotic disorder (anxiety disorders will be allowed as long as MDD is considered the primary psychiatric disorder)
• Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60615, United States

Location

Related Publications (1)

• Grant JE, Redden SA, Leppink EW. Double-blind switch study of vilazodone in the treatment of major depressive disorder. Int Clin Psychopharmacol. 2017 May;32(3):121-126. doi: 10.1097/YIC.0000000000000166.

  PMID: 28177953 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vilazodone Hydrochloride; Citalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Propylamines; Amines; Organic Chemicals; Nitriles

Limitations and Caveats

The sample size was likely too small to make comments about predictors of outcome and generally the study was under-powered, which would make differences difficult to detect. The study design enrolled only non-responders into the double-blind phase.

Results Point of Contact

• Title: Dr. Jon Grant
• Organization: University of Chicago

jongrant@uchicago.edu

773-834-1325

Study Officials

• Jon Grant, MD,JD,MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: May 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 23, 2023
• Results First Posted: May 30, 2017

Record last verified: 2023-02

Locations

US (1)