Efficacy of Hydroxyzine for Patients With Panic Disorder

NCT05737511 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 02/2023
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change in Panic Disorder Severity Scale (PDSS) Mean Score

  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 Outcomes (1)

• Change in Clinical Global Impression Scale (CGI) Mean Score

  8 weeks

Study Arms (2)

Hydroxyzine

EXPERIMENTAL

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

Treatment as Usual

ACTIVE COMPARATOR

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

Drug: Escitalopram Oxalate

Interventions

Hydroxyzine DRUG

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

Also known as: Atarax, Vistaril

Hydroxyzine

Escitalopram Oxalate DRUG

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

Also known as: 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

Treatment as Usual

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sultan Qaboos University: lead

MeSH Terms

Conditions

Panic Disorder

Interventions

Hydroxyzine; Escitalopram; Citalopram; Fluoxetine; Fluvoxamine; Paroxetine; Sertraline; Alprazolam; Clomipramine; Clonazepam; Diazepam; Imipramine; Lorazepam; Mirtazapine; Reboxetine; Valproic Acid; Duloxetine Hydrochloride; Gabapentin; Levetiracetam; Milnacipran; Moclobemide; Olanzapine; Phenelzine; Quetiapine Fumarate; Risperidone; Tranylcypromine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Oximes; Hydroxylamines; Piperidines; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Benzodiazepines; Benzazepines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Benzodiazepinones; Morpholines; Oxazines; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids; Thiophenes; Sulfur Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Acetamides; Amides; Acetates; Pyrrolidinones; Pyrrolidines; Cyclopropanes; Benzamides; Benzoates; Chlorobenzoates; Benzene Derivatives; Hydrazines; Dibenzothiazepines; Thiazepines; Thiepins; Pyrimidinones; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Dr Mohmmed Al Alawi Bsc, MD,PhD, MRCPsych, OMSBPsych, ARABPsych

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: December 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share