Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder

Conditions

• Generalized Anxiety Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ITI-1284 10 mg — DRUG
  ITI-1284 10 mg tablet, taken once daily, sublingual administration.
• ITI-1284 20 mg — DRUG
  ITI-1284 20 mg tablet, taken once daily, sublingual administration.
• Placebo — DRUG
  Matching placebo tablet, taken once daily, sublingual administration

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

Key Dates

Start date

Aug 5, 2024

Status verified

Jan 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

705 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ITI-1284 10mg
• Experimental: ITI-1284 20mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Week 6 ]

Central Contacts

• ITI Clinical Trials
  6464409333
  [email protected]

Locations (34)

Find similar trials in Chandler, AZ

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