ADHDPhase 4NCT00181675
A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder
A Phase 4 study testing galantamine HBr in people with ADHD, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- ADHD
- What is being tested?
- galantamine HBr
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Sep 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
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.
Read more
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- galantamine HBr
- Keywords
- Adult, ADHD, galantamine, double-blind
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galantamine HBrDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom reduction using ADHD- Clinical Global Impression & ADHD Symptom Checklist Severity Scale administered weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2002
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Joseph Biederman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181675
- Sponsor's protocol ID
- 2002-P-001937
- Status last verified
- Jul 2010
- First submitted
- 12 Sep 2005
- Last updated
- 23 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00181675
- Acronym / sponsor ID
- 2002-P-001937
- Conditions
- ADHD
- Keywords
- Adult, ADHD, galantamine, double-blind
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2002
- Study completion
- Sep 2003
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| galantamine HBr | Drug | – |
Primary outcome
symptom reduction using ADHD- Clinical Global Impression & ADHD Symptom Checklist Severity Scale administered weekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Biederman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing galantamine HBr in people with ADHD, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom reduction using ADHD- Clinical Global Impression & ADHD Symptom Checklist Severity Scale administered weekly. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2010.