A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone

Conditions

• Generalized Anxiety Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Cariprazine 0.75 mg/day — DRUG
  Oral Capsule
• Cariprazine 1.5 mg/day — DRUG
  Oral Capsule
• Cariprazine 3.0 mg/day — DRUG
  Oral Capsule
• Placebo — OTHER
  Oral Capsule

Study Details

Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess adverse events and the change in disease activity with cariprazine when added to ADTs compared with placebo in adult participants with GAD who have had an inadequate response to 1 or more prior ADTs alone. Cariprazine is an approved drug being developed for the treatment of GAD. The participants are placed into 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 1072 participants age 18-65 with GAD and an inadequate response to ADT alone will be enrolled in the study in the United States. After a 2-week screening period, participants will receive daily oral capsules of cariprazine of varying doses or placebo for 6 weeks, followed by a 4-week safety follow-up period for a total study duration of 10 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key Dates

Start date

Aug 18, 2021

Status verified

Apr 2022

Primary completion

Aug 24, 2021

Completion

Aug 24, 2021

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cariprazine 0.75 mg/day + Antidepressant Therapy
  Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 0.75 mg/day oral, once daily for 6 weeks
• Experimental: Cariprazine 1.5 mg/day + Antidepressant Therapy
  Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 1.5 mg/day oral, once daily for 6 weeks
• Experimental: Cariprazine 3.0 mg/day + Antidepressant Therapy
  Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 1.5 mg/day oral for 2 weeks followed by cariprazine 3.0 mg/day oral, once daily for 4 weeks.
• Placebo Comparator: Placebo + Antidepressant Therapy
  Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + oral placebo, once daily for 6 weeks

Primary Outcome Measure

Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score [ Time Frame: Week 6 ]

Locations (36)

Find similar trials in Little Rock, AR

Related Studies

• Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
  Recruiting · University of California, Los Angeles · Los Angeles, California
• MBSR Mechanisms in GAD
  Recruiting · NYU Langone Health · New York, New York
• Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety
  Recruiting · University of Texas at Austin · Austin, Texas
• CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy
  Recruiting · Jasper A. Smits · Boston, Massachusetts