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NCT Number: NCT05737511

Efficacy of Hydroxyzine for Patients With Panic Disorder

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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hydroxyzine

Drug

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

Other names: Atarax, Vistaril

Escitalopram Oxalate

Drug

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

Primary outcomes

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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Sultan Qaboos University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Feb 21, 2023
Registry last updated: Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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