Major Depressive DisorderECTAugNCT00988663
The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems?
A study testing memantine in people with Major Depressive Disorder, run by Jerrry L Lewis at 1 site in United States.
Trial summary
The purpose of this study is to determine whether memantine will enhance the therapeutic of effect on depression and prevent memory and other cognitive problems caused by ECT. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- memantine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets criteria for Major Depressive disorder
Who cannot join
- Neurological disease
- Mental retardation
- Seizure disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa hosptitals and clinic
Iowa City, Iowa, 50208
About this study
Official title: Memantine Augmentation of Electroconvulsive Therapy in Patients With Major Depression
The purpose of this study is to determine whether memantine will enhance the therapeutic of effect on depression and prevent memory and other cognitive problems caused by ECT.
Read the detailed description
Patients will be assigned randomly either to a treatment group or a placebo groups. All patients in both groups will be receiving standard ECT. The treatment group will receive memantine. All patients will be given a battery of cognitive tests and test of depression before ECT treatments start, after the 6th ECT treatment and after the completions of ECT. An analysis will be performed to see if memantine causes any impact on the response to ECT and prevents memory and cognitive impairment.
- Conditions
- Major Depressive Disorder
- Being tested
- memantine, Placebo
- Keywords
- electroconvulsive therapy, memantine, cognitive function, memory
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memantineDrug
Also called Namenda
patient will receive 5mg daily for 7day then 10 mgm daily
PlaceboDrug
will give placebo that looks like memantine
| Study group | Role | What they receive |
|---|---|---|
| Memantine arm | Active comparator | Patient receiving ECT and Memantine Receives: Drug: memantine |
| placebo | Placebo comparator | 25 patients receiving ECT will will receive placebo Receives: Drug: memantine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of whether Memantine protects memory and cognitive impairment caused by ECT.
Measured: 6 to 8 weeks
Secondary outcomes (1)
Whether memantine will improve response of Depression to Electroconvulsive therapy.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: PI deceased; study did not start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jerrry L Lewis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jerrry L Lewis, University of Iowa
- Investigators
- Jerry L Lewis, MD, Principal investigator, University of Iowa Hospitals and Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988663
- Sponsor's protocol ID
- Memantine ECT trial
- Acronym
- ECTAug
- Status last verified
- Mar 2017
- First submitted
- 1 Oct 2009
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memantine Augmentation of Electroconvulsive Therapy in Patients With Major Depression
- ClinicalTrials.gov ID
- NCT00988663
- Acronym / sponsor ID
- ECTAug / Memantine ECT trial
- Conditions
- Major Depressive Disorder
- Keywords
- electroconvulsive therapy, memantine, cognitive function, memory
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI deceased; study did not start.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jerrry L LewisUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 2 Oct 2009 (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 this study is to determine whether memantine will enhance the therapeutic of effect on depression and prevent memory and other cognitive problems caused by ECT.
Detailed description
Patients will be assigned randomly either to a treatment group or a placebo groups. All patients in both groups will be receiving standard ECT. The treatment group will receive memantine. All patients will be given a battery of cognitive tests and test of depression before ECT treatments start, after the 6th ECT treatment and after the completions of ECT. An analysis will be performed to see if memantine causes any impact on the response to ECT and prevents memory and cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memantine arm | Active comparator | Drug: memantinePatient receiving ECT and Memantine |
| placebo | Placebo comparator | Drug: memantine, Drug: Placebo25 patients receiving ECT will will receive placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meets criteria for Major Depressive disorder
Key exclusion criteria (3 listed)
- Neurological disease
- Mental retardation
- Seizure disorder
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 |
|---|---|---|
| memantineAlso: Namendapatient will receive 5mg daily for 7day then 10 mgm daily | Drug | Memantine arm, placebo |
| Placebowill give placebo that looks like memantine | Drug | placebo |
Primary outcome
Assessment of whether Memantine protects memory and cognitive impairment caused by ECT.
Time frame: 6 to 8 weeks
1 secondary outcome
Whether memantine will improve response of Depression to Electroconvulsive therapy.
Time frame: 6-8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
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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.
Jerry L Lewis, MD principal investigator
University of Iowa Hospitals and Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing memantine in people with Major Depressive Disorder, run by Jerrry L Lewis 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Mar 2017. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assessment of whether Memantine protects memory and cognitive impairment caused by ECT. (time frame: 6 to 8 weeks). 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 24 Mar 2017.