Efficacy of Hydroxyzine for Patients With Panic Disorder

NCT ID: NCT05737511

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-30
• Study Completion Date: 2026-12-30

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.

Conditions

Panic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hydroxyzine

Hydroxyzine (25 mg/day) for eight weeks, the dose of hydroxyzine may be adjusted based on tolerability and clinical judgment, max 100mg/day

Group Type: EXPERIMENTAL

Hydroxyzine

Intervention Type: DRUG

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

Treatment as Usual

Treatment as usual includes the currently approved treatment according to CANMAT and Muadesly guidelines

Group Type: ACTIVE_COMPARATOR

Escitalopram Oxalate

Intervention Type: DRUG

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

Interventions

Hydroxyzine

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

Intervention Type: DRUG

Escitalopram Oxalate

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

Intervention Type: DRUG

Other Intervention Names

Atarax; Vistaril; 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

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sultan Qaboos University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Al Alawi

Principal Investigator, Dr Mohmmed Al Alawi Bsc, MD,PhD, MRCPsych, OMSBPsych, ARABPsych

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

02/2023

Identifier Type: -

Identifier Source: org_study_id