Efficacy of Hydroxyzine for Patients With Panic Disorder
Status:
Not yet recruiting
Trial end date:
2026-12-30
Target enrollment:
Participant gender:
Summary
The aim of this study is to evaluate the efficacy of hydroxyzine compared to treatment as
usual (TAU) for patients with panic disorder. By conducting a pilot study, we hope to provide
initial data on the feasibility and potential impact of hydroxyzine for this population. This
will inform the design and power calculations of a larger, more comprehensive study in the
future.
Objectives:
To assess the feasibility of conducting a randomized controlled trial (RCT) of hydroxyzine
for panic disorder.
To evaluate the effectiveness of hydroxyzine compared to TAU in reducing panic symptoms in
patients with panic disorder.
To explore the potential side effects and tolerability of hydroxyzine in this population.
Methods:
This will be a single-center, open-label, randomized pilot study. A total of 30 patients with
a primary diagnosis of panic disorder will be recruited from a psychiatric outpatient clinic.
Participants will be randomly assigned to receive either hydroxyzine or TAU for 8 weeks. The
primary outcome measure will be the change in panic symptoms as assessed by the Panic
Disorder Severity Scale (PDSS). Secondary outcome measures will include the Hamilton Anxiety
Rating Scale (HAM-A) and the Clinical Global Impression-Severity (CGI-S) scale. Participants
will be assessed at baseline, 4 weeks, and 8 weeks. Adverse events will be monitored
throughout the study.
Expected Results:
This pilot study is expected to provide preliminary data on the feasibility and potential
efficacy of hydroxyzine for panic disorder. The results will inform the design of a larger
RCT to further evaluate the efficacy of hydroxyzine for this population.
Significance:
There is a need for effective and well-tolerated treatments for panic disorder. If found to
be effective, hydroxyzine could provide a new option for patients with this condition,
potentially improving their quality of life and functioning. The results of this pilot study
will inform the design of future studies and contribute to the development of evidence-based
treatments for panic disorder.