A Phase 4 interventional study of Hydroxyzine and Escitalopram Oxalate in Panic Disorder, sponsored by Sultan Qaboos University. Not yet recruiting. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Sultan Qaboos University · Phase 4, Interventional, and Treatment
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.
270 studies on the registry are indexed under Panic Disorder; 37 are open to participants now.
This study's planned enrollment of 80 is close to the median of 77 across 215 interventional studies indexed under Panic Disorder.
Browse Panic Disorder studies →Sultan Qaboos University is the lead sponsor of 50 studies on the registry; 20 are open to participants now.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 includes the currently approved treatment according to CANMAT and Muadesly guidelines
Drug: Escitalopram Oxalate
Oral tablet of hydroxyzine 25mg at night which could be increased to TID or QID
Also known as: Atarax, Vistaril
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
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.
Time frame: 8 weeks
Change in Clinical Global Impression Scale (CGI) Mean Score
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
Time frame: 8 weeks
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydroxyzine
Sultan Qaboos University