Efficacy of Hydroxyzine for Patients With Panic Disorder

February 20, 2023 updated by: Mohammed Al Alawi, Sultan Qaboos University

Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The study will recruit adult patients (18 years and older)
  • Confirmed diagnosis of the panic disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
  • Participants will be included if they have had at least one panic attack per week for the last four weeks,
  • Have not received any pharmacological treatment for panic disorder in the past four weeks,
  • Willing to discontinue any current benzodiazepine or SSRI treatment for the duration of the study.

Exclusion criteria:

  • Current substance abuse or dependence,
  • Medical diseases
  • Psychiatric comorbidities,
  • Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydroxyzine
Hydroxyzine (25 mg/day) for eight weeks, the dose of hydroxyzine may be adjusted based on tolerability and clinical judgment, max 100mg/day
Drug: Hydroxyzine
Oral tablet of hydroxyzine 25mg at night which could be increased to TID or QID
Other Names:
  • Atarax
  • Vistaril
Active Comparator: Treatment as Usual
Treatment as usual includes the currently approved treatment according to CANMAT and Muadesly guidelines
Drug: Escitalopram Oxalate
The treatment as usual can include first-line, second-line and third-line recommendations
Other Names:
  • citalopram
  • fluoxetine, fluvoxamine, paroxetine, paroxetine CR, sertraline, venlafaxine XR,
  • Alprazolam, clomipramine, clonazepam, diazepam, imipramine, lorazepam, mirtazapine, reboxetine
  • Bupropion SR, divalproex, duloxetine, gabapentin, levetiracetam, milnacipran, moclobemide, olanzapine, phenelzine, quetiapine, risperidone, tranylcypromine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Panic Disorder Severity Scale (PDSS) Mean Score
Time Frame: 8 weeks

The primary outcome measure will be the change in panic disorder severity as measured by the PDSS, which will be completed at baseline, week 4, and week 8.

The Panic Disorder Severity Scale (PDSS) is a self report scale that measures the severity of panic attacks and panic disorder symptoms. It is appropriate for use with adolescents (13+) and adults.

The scale is a useful way of assessing overall panic disorder severity at baseline, and it provides a profile of severity of the different panic disorder symptoms. It is a good monitoring tool because it is brief and sensitive to change, and can be used to track symptoms over time.

The scale consists of seven items, each rated on a 5-point scale. The items assess panic frequency, distress during panic, panic-focused anticipatory anxiety, phobic avoidance of situations, phobic avoidance of physical sensations, impairment in work functioning, and impairment in social functioning.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Global Impression Scale (CGI) Mean Score
Time Frame: 8 weeks
The secondary outcome measure will be the change in clinical global impression as measured by the CGI, which will be completed at baseline, week 4, and week 8
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Qaboos University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 30, 2023

Primary Completion (Anticipated)

December 30, 2026

Study Completion (Anticipated)

December 30, 2026

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Estimate)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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