Efficacy of Hydroxyzine for Patients With Panic Disorder

Sponsor
Sultan Qaboos University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05737511
Collaborator
(none)
80
2
36

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial.
Anticipated Study Start Date :
Dec 30, 2023
Anticipated Primary Completion Date :
Dec 30, 2026
Anticipated Study Completion Date :
Dec 30, 2026

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Panic Disorder Severity Scale (PDSS) Mean Score [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.

    Secondary Outcome Measures

    1. Change in Clinical Global Impression Scale (CGI) Mean Score [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sultan Qaboos University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammed Al Alawi, Principal Investigator, Dr Mohmmed Al Alawi Bsc, MD,PhD, MRCPsych, OMSBPsych, ARABPsych, Sultan Qaboos University
    ClinicalTrials.gov Identifier:
    NCT05737511
    Other Study ID Numbers:
    • 02/2023
    First Posted:
    Feb 21, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2023