Memory, Short-TermPhase 1/2NCT00070954
Ginkgo Biloba to Improve Short-Term Memory Losses Associated With Electroconvulsive Therapy (ECT)
A Phase 1/2 study testing ginkgo biloba in people with Memory, Short-Term, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Electroconvulsive therapy (ECT) is an effective treatment for severe or medication-resistant depression and other psychiatric disorders. A common side effect of ECT is problems with short-term memory during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Memory, Short-Term
- What is being tested?
- ginkgo biloba
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Mar 2005
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of major depressive episode, unipolar or bipolar, without psychotic features
- Receiving ECT for depression
- Able to complete detailed neuropsychological testing
Who cannot join
- Psychotic symptoms
- Lifetime history of schizophrenia, schizoaffective disorder, or mental retardation
- Diagnosis of anxiety disorder, obsessive-compulsive disorder, or eating disorder within 1 year of study entry
- Delirium, dementia, or amnestic disorder
- Any active general medical condition or central nervous system disease which could affect cognition or response to treatment
- Diagnosis of active substance abuse or dependence within 6 months of study entry
Show all 11Show fewer
- ECT within 6 months of study entry
- Known or suspected coagulation disorder
- Anticoagulation or antiplatelet medications, including warfarin, aspirin, clopidogrel, and ticlopidine
- Thiazide diuretics, selective serotonin reuptake inhibitors, trazodone, antipsychotic medications, herbal medications, or other nutritional supplements
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ginkgo Biloba for ECT-induced Memory Deficits
Electroconvulsive therapy (ECT) is an effective treatment for severe or medication-resistant depression and other psychiatric disorders. A common side effect of ECT is problems with short-term memory during treatment. This study will test whether taking ginkgo biloba (GB) prior to and during the course of ECT will lessen the effects of ECT on short-term memory.
Read the detailed description
ECT is a safe and effective modern treatment for severe depression and other psychiatric conditions. An estimated 100,000 treatments occur per year in the United States. ECT's most bothersome adverse effect is memory loss, with all patients receiving ECT experiencing some degree of short-term cognitive impairment. At present there are no known effective pharmacologic treatments to prevent or improve ECT-induced cognitive dysfunction. Preliminary research has shown the herbal preparation GB aids cognitive function and memory in both patients with dementia and in normal volunteers. This study will investigate the utility and safety of GB to minimize the cognitive impairment typically associated with ECT.
Participants in this study will be randomly assigned to receive either twice-daily GB or placebo. Participants will begin taking GB or placebo as soon as consent is obtained and baseline testing is completed in order to reach steady-state plasma levels of GB prior to ECT. Patients will undergo cognitive testing at specified intervals following ECT. The final study visit will occur one week after a participant's final ECT treatment.
- Conditions
- Memory, Short-Term
- Being tested
- ginkgo biloba, matched placebo
- Keywords
- ECT, Memory, Ginkgo biloba
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ginkgo bilobaDrug
Also called ginkgo
EgB 761
matched placeboOther
Inactive look-alike placebo
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | look-alike placebo Receives: Other: matched placebo |
| Ginkgo Biloba | Active comparator | Compared to placebo Receives: Drug: ginkgo biloba |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Mini-Mental State Examination
Measured: 2009
Rey Auditory Verbal Learning Test
Measured: 2009
Autobiographical Memory Inventory
Measured: 2003-2009
Spitzer Uniscale of Quality of Life(Uni)
Measured: 2--3-2009
Health Status Questionnaire
Measured: 2003-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2003 (estimated)
- Study startFeb 2003
- Primary completionJan 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory, Short-TermStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- John S. Markowitz, PharmD, Principal investigator, Medical University of South CarolinaCharles H. Kellner, M.D., Principal investigator, UMDNJ - NJ Medical SchoolThomas W Uhde, MD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070954
- Sponsor's protocol ID
- R21AT000939-01A1
- Other IDs
- R21AT000939-01A1
- Status last verified
- Aug 2008
- First submitted
- 9 Oct 2003
- Last updated
- 18 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ginkgo Biloba for ECT-induced Memory Deficits
- ClinicalTrials.gov ID
- NCT00070954
- Acronym / sponsor ID
- R21AT000939-01A1
- Conditions
- Memory, Short-Term
- Keywords
- ECT, Memory, Ginkgo biloba
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 13 Oct 2003 (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.
Electroconvulsive therapy (ECT) is an effective treatment for severe or medication-resistant depression and other psychiatric disorders. A common side effect of ECT is problems with short-term memory during treatment. This study will test whether taking ginkgo biloba (GB) prior to and during the course of ECT will lessen the effects of ECT on short-term memory.
Detailed description
ECT is a safe and effective modern treatment for severe depression and other psychiatric conditions. An estimated 100,000 treatments occur per year in the United States. ECT's most bothersome adverse effect is memory loss, with all patients receiving ECT experiencing some degree of short-term cognitive impairment. At present there are no known effective pharmacologic treatments to prevent or improve ECT-induced cognitive dysfunction. Preliminary research has shown the herbal preparation GB aids cognitive function and memory in both patients with dementia and in normal volunteers. This study will investigate the utility and safety of GB to minimize the cognitive impairment typically associated with ECT.
Participants in this study will be randomly assigned to receive either twice-daily GB or placebo. Participants will begin taking GB or placebo as soon as consent is obtained and baseline testing is completed in order to reach steady-state plasma levels of GB prior to ECT. Patients will undergo cognitive testing at specified intervals following ECT. The final study visit will occur one week after a participant's final ECT treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Other: matched placebolook-alike placebo |
| Ginkgo Biloba | Active comparator | Drug: ginkgo bilobaCompared to placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM-IV diagnosis of major depressive episode, unipolar or bipolar, without psychotic features
- Receiving ECT for depression
- Able to complete detailed neuropsychological testing
Key exclusion criteria (11 listed)
- Psychotic symptoms
- Lifetime history of schizophrenia, schizoaffective disorder, or mental retardation
- Diagnosis of anxiety disorder, obsessive-compulsive disorder, or eating disorder within 1 year of study entry
- Delirium, dementia, or amnestic disorder
- Any active general medical condition or central nervous system disease which could affect cognition or response to treatment
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 |
|---|---|---|
| ginkgo bilobaAlso: ginkgoEgB 761 | Drug | Ginkgo Biloba |
| matched placeboInactive look-alike placebo | Other | 2 |
Primary outcome
Modified Mini-Mental State Examination
Time frame: 2009
Rey Auditory Verbal Learning Test
Time frame: 2009
Autobiographical Memory Inventory
Time frame: 2003-2009
Spitzer Uniscale of Quality of Life(Uni)
Time frame: 2--3-2009
Health Status Questionnaire
Time frame: 2003-2009
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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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.
John S. Markowitz, PharmD principal investigator
Medical University of South Carolina
Charles H. Kellner, M.D. principal investigator
UMDNJ - NJ Medical School
Thomas W Uhde, MD study chair
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ginkgo biloba in people with Memory, Short-Term, run by Medical University of South Carolina 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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 Jul 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Modified Mini-Mental State Examination (time frame: 2009). The study lists 5 primary outcomes in all. 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 18 Jul 2018.