A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder

Completed · Phase 4

Conditions studied: ADHD

In brief

This will be a double-blind, placebo-controlled, study using daily doses of up to 24 mg/ day Galantamine HBr in the treatment of adults who meet DSM-IV criteria for childhood-onset ADHD. Specific hypotheses are as follows: Hypothesis 1: ADHD symptomatology in adults with DSM-IV ADHD will be responsive to acute Galantamine HBr treatment. Hypothesis 2: Galantamine HBr -associated improvement in ADHD symptomatology in adults will translate into improved functional capacities (neuropsychological, social, and occupational) as well as an increased quality of life throughout acute treatment. Hypothesis 3: Galantamine HBr treatment will be safe and well tolerated as reflected by a low drop out rate and absence of major differences from placebo.

Key facts

Study ID

NCT00181675

Run by

Massachusetts General Hospital

People needed

40

Starts

2002-12-01

Expected to finish

2003-09-01

Last updated by the study team

2010-07-23

Who can join

Age: 18 and older, up to 58. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male outpatients between 18 to 58 years of age (inclusive).
• Females between 18 to 58 years of age (inclusive) that are on reliable and adequate birth control.
• Subjects with the DSM-IV diagnosis of childhood onset Attention-Deficit/Hyperactivity Disorder (ADHD), as manifested in the clinical evaluation and confirmed by structured interview.
• Subjects with a score of 24 or greater on the ADHD Rating Scale.

You may not qualify if…

• Any current, non-ADHD Axis I psychiatric condition of clinical significance.
• Baseline Ham-D > 16, BDI > 19, and/or Ham-A > 21.
• Any clinically significant chronic medical condition, specifically cardiovascular, gastrointestinal, pulmonary, genitourinary, metabolic, or endocrine disorders, and hepatic or renal impairment.
• Clinically significant abnormal baseline laboratory values.
• I.Q. <75.
• Organic brain disorders.
• Subjects with a history of or current seizure disorders.
• Pregnant and/or nursing females.
• Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis).
• Subjects currently (within the past 6 months) known to abuse or to be dependent on any drug, including alcohol.
• Subjects on other psychotropic medications, with the exception of SSRIs.
• Subjects with a history of intolerance or non-response to cholinergic agents as determined by the clinician.
• Subjects with a history of peptic ulcer disease, gastroesophageal reflux disease, or other GI disorders.
• Subjects with history of bradyarrythmias.
• Subjects with asthma.
• Subjects on ketoconazole.

Where it is running

• Massachusetts General Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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