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

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181675
First received: September 12, 2005
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
ADHD
 Drug: galantamine HBr
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • symptom reduction using ADHD- Clinical Global Impression & ADHD Symptom Checklist Severity Scale administered weekly

Estimated Enrollment: 40
Study Start Date: December 2002
Estimated Study Completion Date: September 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 58 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male outpatients between 18 to 58 years of age (inclusive).
  2. Females between 18 to 58 years of age (inclusive) that are on reliable and adequate birth control.
  3. 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.
  4. Subjects with a score of 24 or greater on the ADHD Rating Scale.

Exclusion Criteria:

  1. Any current, non-ADHD Axis I psychiatric condition of clinical significance.
  2. Baseline Ham-D > 16, BDI > 19, and/or Ham-A > 21.
  3. Any clinically significant chronic medical condition, specifically cardiovascular, gastrointestinal, pulmonary, genitourinary, metabolic, or endocrine disorders, and hepatic or renal impairment.
  4. Clinically significant abnormal baseline laboratory values.
  5. I.Q. <75.
  6. Organic brain disorders.
  7. Subjects with a history of or current seizure disorders.
  8. Pregnant and/or nursing females.
  9. Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis).
  10. Subjects currently (within the past 6 months) known to abuse or to be dependent on any drug, including alcohol.
  11. Subjects on other psychotropic medications, with the exception of SSRIs.
  12. Subjects with a history of intolerance or non-response to cholinergic agents as determined by the clinician.
  13. Subjects with a history of peptic ulcer disease, gastroesophageal reflux disease, or other GI disorders.
  14. Subjects with history of bradyarrythmias.
  15. Subjects with asthma.
  16. Subjects on ketoconazole.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181675

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181675     History of Changes
Other Study ID Numbers: 2002-P-001937
Study First Received: September 12, 2005
Last Updated: July 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Adult
ADHD
galantamine
double-blind

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Galantamine
Parasympathomimetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 19, 2013