Methylphenidate Hydrochloride Controlled-Release Capsules for Panic Attacks

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Panic Attacks+9 More
Methylphenidate Hydrochloride Controlled-Release Capsules - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Other psychiatric disorders, including anxiety, often co-occur with adult ADHD; with 85% of ADHD patients having at least one other psychiatric condition. The presence of a co-occurring anxiety disorder has been associated with additive clinical effects, leading to more global impairment, poorer outcome, greater resistance to treatment and increased costs of illness. Stimulants are effective first-line treatments for adult ADHD patients, however the literature has mostly examined these treatments in pure ADHD populations (i.e. without other psychiatric disorders). Thus, there is little information to guide physicians in making treatment decisions for patients with ADHD and a co-occurring condition. This trial aims to evaluate the efficacy and safety of methylphenidate hydrochloride controlled release capsules (Foquest) in treating adults aged 18-65 years with DSM-5 ADHD with and without a co-occurring anxiety disorder.The study uses a 14-week, randomized, placebo-controlled, cross-over design.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Panic Attacks
  • Anxiety Disorders
  • Agoraphobia
  • Phobia, Social

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 21 Secondary · Reporting Duration: Change from baseline to Week 12

Week 12
Alcohol Use Disorders Identification Test (AUDIT)
Attention Deficit and Hyperactivity Rating Scale - 5
Barkley Adult ADHD Rating Scale (BAARS-IV)
Barkley Deficits in Executive Functioning Scale (BDEFS)
Binge Eating Scale (BES)
Cannabis Use Disorder Identification Test-Revised (CUDIT-R)
Clinical Global Impression - Improvement (CGI-I)
Clinical Global Impression - Severity (CGI-S)
Drug Abuse Screening Test (DAST)
Generalized Anxiety Disorder-7
Hamilton Anxiety Rating Scale (HAM-A)
Hoarding Rating Scale (HRS)
Montgomery-Åsberg Depression Rating Scale (MADRS)
Obsessive Compulsive Inventory - Revised (OCI-R)
Overall Anxiety Severity and Impairment Scale (OASIS)
PTSD Checklist for DSM-5 (PCL-5)
Panic and Agoraphobia Scale (PAS)
Pittsburgh Sleep Quality Index (PSQI)
Quick Inventory of Depressive Symptoms (QID-SR-16)
Sheehan Disability Scale (SDS)
Social Phobia Inventory (SPIN)
Weiss Functional Impairment Rating Scale-Self Report (WFIRS-S)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Phase 1-Medication First
51%Appetite Loss
40%Insomnia
33%Irritability
29%Picking at skin, nailbiting
21%Dull, tired, listless
21%Worried/Anxious
19%Tearful, depressed
18%Stomachache
13%Motor Tics
13%Headache
12%Buccal-lingual movements
10%Social Withdrawal
1%Hospitalized
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02039908) in the Phase 1-Medication First ARM group. Side effects include: Appetite Loss with 51%, Insomnia with 40%, Irritability with 33%, Picking at skin, nailbiting with 29%, Dull, tired, listless with 21%.

Trial Design

2 Treatment Groups

Methylphenidate Hydrochloride Controlled-Release Capsules
1 of 2
Placebo Capsules
1 of 2
Experimental Treatment
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Methylphenidate Hydrochloride Controlled-Release Capsules · Has Placebo Group · Phase 4

Methylphenidate Hydrochloride Controlled-Release Capsules
Drug
Experimental Group · 1 Intervention: Methylphenidate Hydrochloride Controlled-Release Capsules · Intervention Types: Drug
Placebo Capsules
Drug
PlaceboComparator Group · 1 Intervention: Placebo Capsule · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to week 12

Who is running the clinical trial?

Purdue Pharma, CanadaIndustry Sponsor
8 Previous Clinical Trials
1,412 Total Patients Enrolled
McMaster UniversityLead Sponsor
791 Previous Clinical Trials
1,456,103 Total Patients Enrolled
Michael Van Ameringen, MD, FRCPCPrincipal InvestigatorMcMaster University
10 Previous Clinical Trials
742 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
MacAnxiety Research Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%