← Back to Search

Central Nervous System Stimulant

Methylphenidate Hydrochloride Controlled-Release Capsules for Agoraphobia

Phase 4
Waitlist Available
Led By Michael Van Ameringen, MD, FRCPC
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Outpatient men and women between 18 and 65 years who meet criteria for Current DSM-5 ADHDalone or with one of the following DSM-5 diagnoses: GAD, SAD,PD or Agoraphobia. Major Depressive Disorder or Persistent Depressive Disorder will be allowed, providing the severity is considered moderate or less, as defined by a score on the Montgomery Depressive Rating Scale-MADRS score of ≤ 25.
ADHD rating scale for DSM-5 (ADHD-5-RS) score ≥ 24.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to week 12
Awards & highlights

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
  • Agoraphobia
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Panic Disorder
  • Generalized Anxiety Disorder
  • Social Anxiety Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Attention Deficit and Hyperactivity Rating Scale - 5
Secondary outcome measures
Alcohol Use Disorders Identification Test (AUDIT)
Barkley Adult ADHD Rating Scale (BAARS-IV)
Barkley Deficits in Executive Functioning Scale (BDEFS)
+18 more

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1-Medication First
Phase 1 - Placebo First
Phase 2 - 7-Day Dosing
Phase 2 - 5-Day Dosing

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Methylphenidate Hydrochloride Controlled-Release CapsulesExperimental Treatment1 Intervention
Flexibly dosed at 25-100 mg per day
Group II: Placebo CapsulesPlacebo Group1 Intervention
1-4 capsules daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
FDA approved

Find a Location

Who is running the clinical trial?

Purdue Pharma, CanadaIndustry Sponsor
8 Previous Clinical Trials
1,424 Total Patients Enrolled
McMaster UniversityLead Sponsor
879 Previous Clinical Trials
2,596,650 Total Patients Enrolled
3 Trials studying Agoraphobia
180 Patients Enrolled for Agoraphobia
Michael Van Ameringen, MD, FRCPCPrincipal InvestigatorMcMaster University
10 Previous Clinical Trials
742 Total Patients Enrolled
3 Trials studying Agoraphobia
220 Patients Enrolled for Agoraphobia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
MacAnxiety Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Michigan
Ontario
How many prior treatments have patients received?
3+
~10 spots leftby Mar 2025