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

NCT00181675 | Completed Phase 4

• 1 other identifier: 2002-P-001937
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Adult; ADHD; galantamine; double-blind

Outcome Measures

Primary Outcomes (1)

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

Interventions

galantamine HBr DRUG

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 2002
• Study Completion: September 1, 2003
• Last Updated: July 23, 2010

Record last verified: 2010-07

Locations

US (1)