search
Back to results

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

Primary Purpose

ADHD

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
galantamine HBr
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring Adult, ADHD, galantamine, double-blind

Eligibility Criteria

18 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

symptom reduction using ADHD- Clinical Global Impression & ADHD Symptom Checklist Severity Scale administered weekly

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
July 22, 2010
Sponsor
Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00181675
Brief Title
A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Official Title
A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital

4. Oversight

5. Study Description

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 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.
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. Initial anecdotal data suggest a promising role for Galantamine HBr in the treatment of ADHD. We propose to study to test the safety and efficacy of Galantamine HBr therapy in adults with ADHD. We will test if Galantamine HBr -associated improvements in ADHD symptomatology translate into improved cognitive and functional capacities (social and occupational) as well as increased quality of life. The proposed study includes 1) use of a 12-week design to document the response rate 2) assessment of the impact of Galantamine HBr on functional capacities (quality of life, psychosocial function) and cognition, 3) careful assessment of safety and tolerability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
Adult, ADHD, galantamine, double-blind

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
galantamine HBr
Primary Outcome Measure Information:
Title
symptom reduction using ADHD- Clinical Global Impression & ADHD Symptom Checklist Severity Scale administered weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Biederman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs