Status:
COMPLETED
A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
Massachusetts General Hospital
Conditions:
ADHD
Eligibility:
All Genders
18-58 years
Phase:
PHASE4
Brief Summary
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 hypo...
Detailed Description
Galantamine HBr, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase that is indicated to slow the deterioration of cognitive impairment in Alzheimer's Disease. Init...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00181675
Start Date
December 1 2002
End Date
September 1 2003
Last Update
July 23 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138