A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 20, 2019

Primary Completion Date

September 30, 2022

Study Completion Date

October 31, 2022

Conditions
Attention Deficit Hyperactivity DisorderGeneralized Anxiety DisorderSocial Anxiety DisorderPanic DisorderAgoraphobia
Interventions
DRUG

Methylphenidate Hydrochloride Controlled-Release Capsules

"25 mg methylphenidate hydrochloride- titrated as tolerated up to a maximum 4 capsules daily (25 mg- 100 mg total dose)~At Week 0 or Week 7, dosing will start at 1 capsule/day for one week, and be titrated to 2 capsules/day for Week 2. 50 mg of methylphenidate hydrochloride per day (i.e. 2 capsules/day) is the minimum dose that must be achieved. The dose may be titrated to 75 mg/day for Week 3 and to 100 mg/day for Week 4 if participants are tolerating their current dose, are experiencing no adverse events, and have not fully responded. By Week 4 or Week 11, no further dose changes will occur."

DRUG

Placebo Capsule

At Week 0 or Week 7, dosing will start at 1 capsule/day for one week, and be titrated to 2 capsules/day for Week 2. The dose may be titrated to 75 mg/day for Week 3 and to 100 mg/day for Week 4 if participants are tolerating their current dose, are experiencing no adverse events, and have not fully responded. By Week 4 or Week 11 no further dose changes will occur.

Trial Locations (1)

L8S 1B7

MacAnxiety Research Center, Hamilton

All Listed Sponsors
lead

McMaster University

OTHER

collaborator

Purdue Pharma, Canada

INDUSTRY

NCT03785223 - A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity | Biotech Hunter | Biotech Hunter