DepressionNCT02238730
Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy
A study testing Ultrabrief Right Unilateral and Brief Pulse Bitemporal in people with Depression and Depressive Disorder, run by Kaiser Permanente.
Trial summary
To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral electroconvulsive therapy versus bitemporal brief pulse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depressive Disorder, Treatment Resistant Depressive Disorder
- What is being tested?
- Ultrabrief Right Unilateral and Brief Pulse Bitemporal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to 15 Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients age 18 and above referred for electroconvulsive therapy will be screened for eligibility for participation in this study.
- Basic competency in English
- Diagnosis of either of the following:
- Major Depressive Disorder, Single Episode
- Major Depressive Disorder, Recurrent
- Bipolar Disorder, Currently Depressed
Who cannot join
- Pre-existing cognitive impairment with an initial Mini Mental Status Exam Score of 24 or lower
- Major neurological disease
- Other medical conditions making electroconvulsive therapy an excessive risk to be completed safely in an outpatient surgery center and anticonvulsant therapy.
- Pregnancy
About this study
Official title: Comparative Efficacy and Cognitive Side-Effects of Ultrabrief Right Unilateral Electroconvulsive Therapy and Brief Pulse Bitemporal Electroconvulsive Therapy
To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.
Read the detailed description
Patients will be randomized to either bitemporal brief pulse electroconvulsive therapy ( 0.5 ms pulse width) or right unilateral ultrabrief pulse electroconvulsive therapy for the first six treatments. If further treatment is necessary, electrode placement will be chosen by the treating psychiatrist. All electroconvulsive therapy treatments will be performed with a Thymatron System IV instrument. (Somatics, LLC, Lake Bluff, Illinois, USA) Pre- electroconvulsive therapy testing will occur within one week of beginning treatment. Post-electroconvulsive therapy testing will occur within 48 hours of the 6th treatment.
- Conditions
- Depression, Depressive Disorder, Treatment Resistant Depressive Disorder, Bipolar Disorder, Major Depressive Disorder
- Being tested
- Ultrabrief Right Unilateral, Brief Pulse Bitemporal
- Keywords
- Depression, Depressive Disorder, Treatment Resistant Depressive Disorder, Bipolar Disorder, Major Depressive Disorder, Electroconvulsive therapy
- Medical subject headings
- Depression, Depressive Disorder, Depressive Disorder, Treatment-Resistant, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrabrief Right UnilateralDevice
Also called Thymatron System IV
The first six electroconvulsive therapy sessions using ultrabrief (0.25 ms) right unilateral electroconvulsive therapy
Brief Pulse BitemporalDevice
Also called Thymatron System IV
The first six electroconvulsive therapy sessions using brief pulse (0.5 ms) bitemporal electroconvulsive therapy
| Study group | Role | What they receive |
|---|---|---|
| Ultrabrief Right Unilateral | Active comparator | Ultrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy Receives: Device: Ultrabrief Right Unilateral |
| Brief Pulse Bitemporal | Active comparator | Brief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy Receives: Device: Brief Pulse Bitemporal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAMD)
Standardized assessment administered by a psychologist
Measured: up to 2-3 weeks
Secondary outcomes (1)
Mini Mental Status Examination
Standardized assessment administered by a psychologist
Measured: up to 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Why it stopped: Resources not available for the 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 Kaiser PermanenteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronad L Warnell, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238730
- Sponsor's protocol ID
- KPSC IRB10133
- Other IDs
- KPSC IRB 10133
- Status last verified
- Feb 2017
- First submitted
- 10 Sep 2014
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Cognitive Side-Effects of Ultrabrief Right Unilateral Electroconvulsive Therapy and Brief Pulse Bitemporal Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT02238730
- Acronym / sponsor ID
- KPSC IRB10133
- Conditions
- Depression, Depressive Disorder, Treatment Resistant Depressive Disorder, Bipolar Disorder, Major Depressive Disorder
- Keywords
- Depression, Depressive Disorder, Treatment Resistant Depressive Disorder, Bipolar Disorder, Major Depressive Disorder, Electroconvulsive therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Resources not available for the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 12 Sep 2014 (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.
To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.
Detailed description
Patients will be randomized to either bitemporal brief pulse electroconvulsive therapy ( 0.5 ms pulse width) or right unilateral ultrabrief pulse electroconvulsive therapy for the first six treatments. If further treatment is necessary, electrode placement will be chosen by the treating psychiatrist. All electroconvulsive therapy treatments will be performed with a Thymatron System IV instrument. (Somatics, LLC, Lake Bluff, Illinois, USA) Pre- electroconvulsive therapy testing will occur within one week of beginning treatment. Post-electroconvulsive therapy testing will occur within 48 hours of the 6th treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrabrief Right Unilateral | Active comparator | Device: Ultrabrief Right UnilateralUltrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy |
| Brief Pulse Bitemporal | Active comparator | Device: Brief Pulse BitemporalBrief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients age 18 and above referred for electroconvulsive therapy will be screened for eligibility for participation in this study.
- Basic competency in English
- Diagnosis of either of the following:
Key exclusion criteria (4 listed)
- Pre-existing cognitive impairment with an initial Mini Mental Status Exam Score of 24 or lower
- Major neurological disease
- Other medical conditions making electroconvulsive therapy an excessive risk to be completed safely in an outpatient surgery center and anticonvulsant therapy.
- Pregnancy
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 |
|---|---|---|
| Ultrabrief Right UnilateralAlso: Thymatron System IVThe first six electroconvulsive therapy sessions using ultrabrief (0.25 ms) right unilateral electroconvulsive therapy | Device | Ultrabrief Right Unilateral |
| Brief Pulse BitemporalAlso: Thymatron System IVThe first six electroconvulsive therapy sessions using brief pulse (0.5 ms) bitemporal electroconvulsive therapy | Device | Brief Pulse Bitemporal |
Primary outcome
Hamilton Depression Rating Scale (HAMD)
Time frame: up to 2-3 weeks
Standardized assessment administered by a psychologist
1 secondary outcome
Mini Mental Status Examination
Time frame: up to 2-3 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 17 Feb 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.
Ronad L Warnell, MD principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A study testing Ultrabrief Right Unilateral and Brief Pulse Bitemporal in people with Depression and Depressive Disorder, run by Kaiser Permanente.
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 4 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Hamilton Depression Rating Scale (HAMD) (time frame: up to 2-3 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 17 Feb 2017.