Bipolar DisorderNCT00181636
Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder
A study testing Galantamine-CR in people with Bipolar Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is to determine whether the investigational drug galantamine-CR (Reminyl- Controlled Release capsule) is useful in improving problems with memory in bipolar patients with stable mood. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Galantamine-CR
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Oct 2006
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnostic criteria for bipolar disorder
- men or women aged 18-65
- a baseline Hamilton-D17 score of < 10 at screen visit
- a baseline YMRS score of < 10 at screen visit
- no acute episodes of depression or mania for the previous 12 weeks.
- written informed consent
Who cannot join
- Subjects with current suicidal ideation
- Pregnant women or women of childbearing potential
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease; History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
- History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months
- History of multiple adverse drug reactions
- Patients with mood congruent or mood incongruent psychotic features Subjects who are active smokers or who stopped smoking less than 3 months prior to enrollment; Clinical or laboratory evidence of hypothyroidism
Show all 10Show fewer
- Patients who have had an episode of acute depression or mania during the 12 weeks prior to enrollment
- Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment
- Patients with physical contraindications to magnetic resonance spectroscopy (ferrous surgical clips, cardiac pacemakers, ferrous prosthesis)
- Patients taking any of the following medications: other cholinesterase inhibitors, succinylcholine, neuromuscular blocking agents, cholinergic agonists (e.g., bethanechol), cimetidine, ketoconazole, erythromycin, fluoxetine, paroxetine, and fluvoxamine
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Bipolar Clinic and Research Program
Boston, Massachusetts, 02114
About this study
The purpose of the study is to determine whether the investigational drug galantamine-CR (Reminyl- Controlled Release capsule) is useful in improving problems with memory in bipolar patients with stable mood. This study is being done because a large proportion of patients with bipolar disorder experience significant memory problems, even when their mood is stable, after adequate treatment. These memory problems have been associated with poor daily social functioning. Studying galantamine-CR in this population may provide a new clinical way to combat memory problems in stable patients with bipolar disorder.
- Conditions
- Bipolar Disorder
- Being tested
- Galantamine-CR
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galantamine-CRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
neurocognitive testing at last study visit (18 weeks)
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 completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dan V Iosifescu, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181636
- Sponsor's protocol ID
- 2003P-000030/24
- Status last verified
- Apr 2007
- First submitted
- 12 Sep 2005
- Last updated
- 24 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Iosifescu DV, Moore CM, Deckersbach T, Tilley CA, Ostacher MJ, Sachs GS, Nierenberg AA. Galantamine-ER for cognitive dysfunction in bipolar disorder and correlation with hippocampal neuronal viability: a proof-of-concept study. CNS Neurosci Ther. 2009 Winter;15(4):309-19. doi: 10.1111/j.1755-5949.2009.00090.x.
PubMed 19889129
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00181636
- Acronym / sponsor ID
- 2003P-000030/24
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study completion
- Oct 2006 (actual)
- 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.
The purpose of the study is to determine whether the investigational drug galantamine-CR (Reminyl- Controlled Release capsule) is useful in improving problems with memory in bipolar patients with stable mood. This study is being done because a large proportion of patients with bipolar disorder experience significant memory problems, even when their mood is stable, after adequate treatment. These memory problems have been associated with poor daily social functioning. Studying galantamine-CR in this population may provide a new clinical way to combat memory problems in stable patients with bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DSM-IV diagnostic criteria for bipolar disorder
- men or women aged 18-65
- a baseline Hamilton-D17 score of < 10 at screen visit
- a baseline YMRS score of < 10 at screen visit
- no acute episodes of depression or mania for the previous 12 weeks.
Key exclusion criteria (10 listed)
- Subjects with current suicidal ideation
- Pregnant women or women of childbearing potential
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease; History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
- History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months
- History of multiple adverse drug reactions
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-CR | Drug | – |
Primary outcome
neurocognitive testing at last study visit (18 weeks)
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 24 Apr 2007.
- Derived from this study: PubMed 19889129Iosifescu DV, Moore CM, Deckersbach T, Tilley CA, Ostacher MJ, Sachs GS, Nierenberg AA. Galantamine-ER for cognitive dysfunction in bipolar disorder and correlation with hippocampal neuronal viability: a proof-of-concept study. CNS Neurosci Ther. 2009 Winter;15(4):309-19. doi: 10.1111/j.1755-5949.2009.00090.x.
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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.
Dan V Iosifescu, 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 study testing Galantamine-CR in people with Bipolar Disorder, 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 6 inclusion and 10 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 24 Apr 2007. 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.
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?
neurocognitive testing at last study visit (18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00181636, which also lists 1 linked publication.
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 24 Apr 2007.