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

Browse trials for

• Depressive Disorder 4,845
• Depression 8,057
• Depressive Disorder, Major 2,741

Keywords

• Major Depressive Disorder
• Vilazodone

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 70 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Study arms

• Experimental
  Vilazodone 10mg

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

  Drug: Vilazodone

• Experimental
  Vilazodone 20mg

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

  Drug: Vilazodone

• Experimental
  Vilazodone 40mg

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

  Drug: Vilazodone

Interventions

• DrugVilazodone

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

  Also known as: Viibryd

Primary outcomes

1. Change in Total MADRS Scores From Baseline to Week 8

   The efficacy of switching to three different doses of vilazodone (10 mg/d, 20 mg/d, 40 mg/d) from equivalent dose range of generic SSRIs or SSNRIs in patients with MDD measured by the MADRS. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.

   Time frame: Baseline, Week 8

2. Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS)

   DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The primary tolerability measure for discontinuation symptoms will be The Discontinuation Emergent Signs and Symptoms Check List (DESS). Discontinuation symptoms that do not respond to education and supportive psychotherapy will be managed by reinstituting the last dose of Vilazodone at which patients did not experience discontinuation symptoms and slowly tapering the dose over 1 week or longer, if necessary. Total possible range is 0 to 172. A higher score indicates more symptoms.

   Time frame: Baseline, week 9

3. Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX)

   The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction.

   Time frame: Baseline, Weeks 8

Secondary outcomes

1. Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores

   HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, \& restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.

   Time frame: Baseline, 8 weeks

2. Change in Sheehan Disability Scale (SDS)

   The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.

   Time frame: Baseline, 8 week

3. Change in Clinical Global Impression-Improvement (CGI-I) Scale

   The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

   Time frame: Baseline, Week 8

4. Change in Clinical Global Impression-Severity (CGI-S) Scale

   The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.

   Time frame: Baseline, 8 week

5. MADRS Response

   Number of subjects who had a ≥ 50% decrease in MADRS score from baseline

   Time frame: Baseline, Week 8

6. MADRS Remission

   MADRS remission is defined as MADRS score \< 10

   Time frame: Week 8

Baseline characteristics

Publications

• 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. PubMed 26693034 ↗