Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

Browse trials for

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

Keywords

• MDD
• Major Depressive Disorder

Depressive Disorder

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

This study's enrollment of 1,022 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Study arms

• Other
  Placebo + ADT Lead-in

  Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.

  Drug: Placebo · Drug: Antidepressant Therapy (ADT)

• Placebo comparator
  Placebo + ADT (Double-Blind)

  Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).

  Drug: Placebo · Drug: Antidepressant Therapy (ADT)

• Experimental
  Cariprazine + ADT (Double-Blind)

  Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).

  Drug: Cariprazine · Drug: Antidepressant Therapy (ADT)

• Other
  Placebo + ADT (Continued Treatment)

  Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.

  Drug: Placebo · Drug: Antidepressant Therapy (ADT)

Interventions

• DrugCariprazine

  Cariprazine capsules 1.5 to 4.5 mg/day

• DrugPlacebo

  Dose-matched placebo capsule once per day

• DrugAntidepressant Therapy (ADT)

  ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.

Primary outcomes

1. Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period

   The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.

   Time frame: Baseline (Week 8)

2. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period

   The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.

   Time frame: Baseline (Week 8) to Week 16

Secondary outcomes

1. Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period

   The Sheehan Disability Scale (SDS) is a 3-item patient-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe). The 3 individual scores are summed for a total possible score of 0 (unimpaired) to 30 (highly impaired). A negative change from Baseline indicates improvement. MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.

   Time frame: Baseline (Week 8) to Week 16

Baseline characteristics

Publications

• Earley WR, Guo H, Nemeth G, Harsanyi J, Thase ME. Cariprazine Augmentation to Antidepressant Therapy in Major Depressive Disorder: Results of a Randomized, Double-Blind, Placebo-Controlled Trial. Psychopharmacol Bull. 2018 Jun 20;48(4):62-80. PubMed 30618475 ↗