- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05737511
Efficacy of Hydroxyzine for Patients With Panic Disorder
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Oral tablet of hydroxyzine 25mg at night which could be increased to TID or QID
Other Names:
|
Active Comparator: Treatment as Usual
Treatment as usual includes the currently approved treatment according to CANMAT and Muadesly guidelines
|
The treatment as usual can include first-line, second-line and third-line recommendations
Other Names:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Anxiety Disorders
- Panic Disorder
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Non-Narcotic
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine Antagonists
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Cytochrome P-450 Enzyme Inhibitors
- Anticonvulsants
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Antidepressive Agents, Tricyclic
- Antimanic Agents
- Cytochrome P-450 CYP2D6 Inhibitors
- Serotonin 5-HT3 Receptor Antagonists
- Dopamine Uptake Inhibitors
- Monoamine Oxidase Inhibitors
- Neuromuscular Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Nootropic Agents
- Cytochrome P-450 CYP1A2 Inhibitors
- Adrenergic Uptake Inhibitors
- Adrenergic alpha-Antagonists
- Muscle Relaxants, Central
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Adrenergic alpha-2 Receptor Antagonists
- Cytochrome P-450 CYP2C19 Inhibitors
- Olanzapine
- Sertraline
- Duloxetine Hydrochloride
- Citalopram
- Clomipramine
- Gabapentin
- Paroxetine
- Bupropion
- Quetiapine Fumarate
- Risperidone
- Diazepam
- Dexetimide
- Venlafaxine Hydrochloride
- Mirtazapine
- Fluoxetine
- Levetiracetam
- Fluvoxamine
- Lorazepam
- Alprazolam
- Clonazepam
- Tranylcypromine
- Milnacipran
- Hydroxyzine
- Reboxetine
- Phenelzine
- Imipramine
- Moclobemide
Other Study ID Numbers
- 02/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Panic Disorder
-
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Ruhr University of BochumTerminatedPanic Disorder With AgoraphobiaGermany
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