Switching From Generic Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) to Three Different Dose Initiation Strategies With Vilazodone

NCT ID: NCT02015546

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-12-31

Brief Summary

This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10 mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S. FDA for the treatment of major depressive disorder in adults. The purpose of this study is to evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent the recurrence of depression, for the purposes of this study it is considered investigational. The word "investigational" means that the study drug is still being tested in research studies and has not been approved for this use by the FDA.

Conditions

Major Depressive Disorder (MDD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vilazodone 10mg

Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)

Group Type: EXPERIMENTAL

Vilazodone

Intervention Type: DRUG

All subjects will receive Vilazodone at 10, 20 or 40mg.

Vilazodone 20mg

vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)

Group Type: EXPERIMENTAL

Vilazodone

Intervention Type: DRUG

All subjects will receive Vilazodone at 10, 20 or 40mg.

Vilazodone 40mg

vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.

Group Type: EXPERIMENTAL

Vilazodone

Intervention Type: DRUG

All subjects will receive Vilazodone at 10, 20 or 40mg.

Interventions

Vilazodone

All subjects will receive Vilazodone at 10, 20 or 40mg.

Intervention Type: DRUG

Other Intervention Names

Viibryd

Eligibility Criteria

Inclusion Criteria

1. Age 18-65 years inclusive

2. DSM-IV Diagnosis of major depressive disorder

3. If female, nonpregnant/nonlactating

4. If a sexually active female of reproductive potential, must be using adequate contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation)

5. Inadequate response to antidepressants: having a score of ≥14 on the 17-item HAMD or a CGI-S score of ≥ 3 after a retrospective confirmation of an adequate trial of a single antidepressant (defined as an 6-week trial of acceptable therapeutic dose [40 mg of fluoxetine, paroxetine 30 mg of citalopram, 20 mg of escitalopram, 37.5 mg of paroxetine CR, 150 mg of sertraline, 100 mg of fluvoxamine, 225 mg of venlafaxine XR)

6. Lack of tolerability of antidepressants: Patient reports of side effects that are judged to be clinically meaningful by the investigator

7. HAMD item 2 score ≥ 2 at screening

8. Duration of current MDD ≥ 4 weeks and < 24 months

Exclusion Criteria

1. Any Axis I disorder within previous six months of screening except Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder and Simple Phobias

2. MDD with postpartum onset, psychotic features or seasonal features

3. DSM-IV substance abuse or dependence in the previous 6 months

4. Medically unstable as judged by study investigators on clinical and/or laboratory findings

5. Lack of capacity to provide informed, written, consent to investigators

6. Previous intolerance to vilazodone or current use of vilazodone at screening or within 3 months of study entry

7. Significant suicide risk as judged by the investigator based on information collected on the Columbia Suicide Severity Rating Scale (CSSRS)

8. History of augmentation with atypical antipsychotics, lithium, T3 or another antidepressant within 3 months of screening

9. Failure of ≥ 3 adequate trials of different antidepressants for the current episode of MDD

10. Concomitant medications: All medications for pre existing medical conditions will be permitted to continue unchanged provided subjects are on a stable dose of at least 12 weeks. Subjects on concomitant mood stabilizers or atypical antipsychotics will require a 2-week washout prior to screening visit. Subjects on a minimum of 3 month of stable dose of hypnotics (e.g. zolpidem 10 mg per day or benzodiazepine dose of ≤ 2 mg per day of lorazepam or trazodone ≤ 100 mg per day or quetiapine ≤ 100 mg per day) will be allowed to continue their hypnotic medication at the same dose. Quetiapine at doses ≤ 100 mg per day is appropriate only for hypnotic effects. Over the counter medications will be permitted if in the opinion of the investigator, they are not considered to have any significant impact on the study. Any medication that has the potential to cause a clinical significant drug interaction with vilazodone in the judgment of the investigator will require a washout.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashwin A Patkar, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Health Systems

Locations

Duke University Medical Center / Civitan Building

Durham, North Carolina, United States

Countries

United States

References

Rele S, Millet R, Kim S, Paik JW, Kim S, Masand PS, Patkar AA. An 8-Week Randomized, Double-Blind Trial Comparing Efficacy, Safety, and Tolerability of 3 Vilazodone Dose-Initiation Strategies Following Switch From SSRIs and SNRIs in Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Aug 6;17(4):10.4088/PCC.14m01734. doi: 10.4088/PCC.14m01734. eCollection 2015.

Reference Type: DERIVED

PMID: 26693034 (View on PubMed)

Other Identifiers

Pro00036210

Identifier Type: -

Identifier Source: org_study_id