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Efficacy of Hydroxyzine for Patients With Panic Disorder

NCT05737511 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-21

No results posted yet for this study

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.

Conditions

  • Panic Disorder

Interventions

DRUG

Hydroxyzine

Oral tablet of hydroxyzine 25mg at night which could be increased to TID or QID

DRUG

Escitalopram Oxalate

The treatment as usual can include first-line, second-line and third-line recommendations

Sponsors & Collaborators

  • Sultan Qaboos University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-30
Primary Completion
2026-12-30
Completion
2026-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05737511 on ClinicalTrials.gov