DepressionNCT00750906
ECT/Succinylcholine: Biochemical, Serum and Cardiovascular Changes
An observational study of Depression, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study will be conducted to determine the pharmacodynamics, cardiovascular and biochemical effects of succinylcholine when given during electroconvulsive therapy. (ECT). This is a single center, prospective, study in patients who will be receiving ECT as indicated and prescribed by their psychiatrist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to 30 Apr 2015
- Phase
- Observational
- 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
Study population: Patients undergoing electroconvulsive therapy.
Who may be able to join
- A male or non-pregnant female aged 18 years and older
- American Society of Anesthesiologists physical status 1, 2, 3
- Scheduled to undergo electroconvulsive therapy under general anesthesia
- Have given written informed consent
Who cannot join
- Pregnant or nursing
- Any patient in the study investigators opinion who may not be suitable for research.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: The Muscle Biochemical, Serum Potassium and Cardiovascular Changes After Succinylcholine in Patients Undergoing Electroconvulsive Therapy.
This study will be conducted to determine the pharmacodynamics, cardiovascular and biochemical effects of succinylcholine when given during electroconvulsive therapy. (ECT). This is a single center, prospective, study in patients who will be receiving ECT as indicated and prescribed by their psychiatrist. The study will be performed twice on each patient, 48-72 hours apart during consecutively scheduled ECT procedures.
Read the detailed description
Patients will receive the anesthetic that is traditionally given which includes appropriate doses of succinylcholine. Serum potassium and creatinine phosphokinase (CK) levels will be determined pre and post anesthesia; serum and urine myoglobin will be determined post anesthesia. Vital signs data [i.e., heart rate (arrhythmias) and arterial blood pressure] will be compared pre and post anesthesia. In addition patients will be asked about the presence of muscle pain (myalgia) 1 hour before discharge from the recovery room and the following day post ECT.
- Conditions
- Depression
- Medical subject headings
- Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startOct 2008
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Why it stopped: Study on hold since 2009. Awaiting FDA approval of Sugammdex to complete second arm of study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald D Miller, MD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750906
- Sponsor's protocol ID
- H898-32701
- Status last verified
- Jan 2020
- First submitted
- 9 Sep 2008
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Muscle Biochemical, Serum Potassium and Cardiovascular Changes After Succinylcholine in Patients Undergoing Electroconvulsive Therapy.
- ClinicalTrials.gov ID
- NCT00750906
- Acronym / sponsor ID
- H898-32701
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study on hold since 2009. Awaiting FDA approval of Sugammdex to complete second arm of study.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 11 Sep 2008 (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 study will be conducted to determine the pharmacodynamics, cardiovascular and biochemical effects of succinylcholine when given during electroconvulsive therapy. (ECT). This is a single center, prospective, study in patients who will be receiving ECT as indicated and prescribed by their psychiatrist. The study will be performed twice on each patient, 48-72 hours apart during consecutively scheduled ECT procedures.
Detailed description
Patients will receive the anesthetic that is traditionally given which includes appropriate doses of succinylcholine. Serum potassium and creatinine phosphokinase (CK) levels will be determined pre and post anesthesia; serum and urine myoglobin will be determined post anesthesia. Vital signs data [i.e., heart rate (arrhythmias) and arterial blood pressure] will be compared pre and post anesthesia. In addition patients will be asked about the presence of muscle pain (myalgia) 1 hour before discharge from the recovery room and the following day post ECT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing electroconvulsive therapy.
Key inclusion criteria (4 listed)
- A male or non-pregnant female aged 18 years and older
- American Society of Anesthesiologists physical status 1, 2, 3
- Scheduled to undergo electroconvulsive therapy under general anesthesia
- Have given written informed consent
Key exclusion criteria (2 listed)
- Pregnant or nursing
- Any patient in the study investigators opinion who may not be suitable for research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Study on hold since 2009. Awaiting FDA approval of Sugammdex to complete second arm of study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
Ronald D Miller, MD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by University of California, San Francisco 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 2 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 Jan 2020. 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 was stopped early (reason given: Study on hold since 2009. Awaiting FDA approval of Sugammdex to complete second arm of study.). 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.
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 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.