AzTrials
AzTrials

CatatoniaNCT02734498

Prospective Treatment Study of Catatonia Patients

A study testing Electroconvulsive Treatment (ECT) Right Unilateral and Electroconvulsive Treatment (ECT) - Bilateral in people with Catatonia, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this treatment study is to compare the effectiveness of different electrode placements used in Electroconvulsive Therapy (ECT) in the treatment of catatonia. In this study Electroconvulsive Therapy will be compared to medications used in the treatment of catatonia. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Catatonia
What is being tested?
Electroconvulsive Treatment (ECT) Right Unilateral and Electroconvulsive Treatment (ECT) - Bilateral
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Jan 2017to 19 Mar 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients admitted to WFBMC Inpatient Psychiatry unit with catatonia who are clinically eligible for ECT.
  • Clinical catatonia as evidenced by a Bush-Francis Catatonia Rating Scale (BFCRS) score of 4 or more

Who cannot join

  • Pregnant women
  • Patients with any of the following medical conditions which are contraindications for ECT:
  • Pheochromocytoma
  • History of stroke within the past 3 months
  • Cardiac conduction defects
  • Cerebral or aortic aneurysms

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official title: Prospective Treatment Study of Catatonia Patients With Right Unilateral Electroconvulsive Treatment (RUL ECT) and Bilateral Electroconvulsive Treatment (BL ECT) Regimens

The purpose of this treatment study is to compare the effectiveness of different electrode placements used in Electroconvulsive Therapy (ECT) in the treatment of catatonia. In this study Electroconvulsive Therapy will be compared to medications used in the treatment of catatonia. Medications will be administered by the primary team as part of standard of care. Medications are not primarily being used as a part of this research study.

This treatments study, will be able to compare response rate of catatonia to right unilateral electroconvulsive treatment (RUL ECT) and Bilateral electroconvulsive treatment (BL ECT). Also having a control group of catatonia patients, which will not be treated with ECT will provide additional information on early ECT treatment of Catatonia.

Read the detailed description

Catatonia was first described in 1873 by a German psychiatrist, Karl Ludwig Kahlbaum in his monograph titled ''Die Katatonie oder Das Spannungsirresein'' (Catatonia or tension insanity) (Kahlbaum, 1873). He conceptualized catatonia as a motor syndrome characterized by lack of motion, speech, alternating with periods of excessive purposeful motor activity, rigidity, negativism, verbigeration, automatic imbalance, posturing, grimacing and stereotypes. He also described that the syndrome generally had a periodic course and lethal outcome in a few. Despite a long history, "katatonia" was associated with different illnesses and was given as diagnostic specifier. DSM- V made a change and added catatonia as an independent diagnostic symptom.

According to DSM-V, catatonia is characterized by the following:

  1. the clinical picture is dominated by 3 or more of the following symptoms (1) Stupor (2) Catalepsy (3) Waxy flexibility (4) Mutism (5) Negativism (6) Posturing (7) Mannerism (8) Stereotypy (9) Agitation (10) Grimacing (11) Echolalia (12) Echopraxia
  2. There is evidence from the history, physical examination or laboratory findings that the disturbance is in the direct patho-physiological consequence of another medical condition.
  3. The disturbance is not better explained by another mental disorder
  4. the disturbance does not occur exclusively during the course of a delirium
  5. The disturbance causes clinically significant distress or impairment in social, occupational or other important areas of functioning

Electroconvulsive therapy has a very good track record in treatment of catatonia (World J Psychiatr. 2015 June 22; 5(2): 182-192), but current literature does not shed light on the speed and degree of response of catatonia to ECT. This study aims to analyze and describe the change of clinical signs and symptoms as a response parameter to judge ECT treatment series efficacy.

This treatment study, will be able to compare response rate of catatonia to right unilateral electroconvulsive treatment (RUL ECT) and Bilateral electroconvulsive treatment (BL ECT). Also having a control group of catatonia patients, which will not be treated with ECT will provide additional information on early ECT treatment of Katatonia.

Objectives:

  1. To study the response rate of catatonia to right unilateral (RUL) ECT and bilateral (BL) ECT.
  2. To compare response rate of catatonia to RUL ECT and BL ECT
  3. To analyze and describe the change of clinical signs and symptoms after ECT treatment series

Methods and Measures:

Design This study is a case control study. Currently ECT is considered standard of treatment for catatonia in addition to alternative medication options.

Study participants meeting inclusion and exclusion criteria will be and providing informed consent will be randomly assigned to receive either bilateral electroconvulsive treatment (BL ECT) or right unilateral electroconvulsive treatment (RUL ECT).

  • Patients who are otherwise eligible and consent to participate in our study, but refuse ECT (or ones who are unable to consent but their court appointed legal guardian or health care power of attorney refuse ECT) will be enrolled as a control group. The control group will undergo all the same laboratory investigations and Bush Francis measurements for evaluation of their catatonia but will not receive ECT.
  • Informed consent will be obtained from the study participant or their legally authorized representative by the principal investigator or sub-investigator.
  • Prior to treatment each patient will be examined by a clinician (psychiatrist and psychiatric resident) in which the following information will be obtained:
  1. Psychiatric interview with uniformed questioner
  2. History of the present illness (HPI) with onset, course of presenting symptoms, comorbidities, precipitating illness or life events - emphasis upon psychological stress
  3. Substance abuse screening
  4. Psychiatric history - Psychiatric diagnoses with age/date of diagnoses
  5. Medical history, with focus on comorbid developments and chronic medical disease states - especially if recent worsening or change in therapy
  6. Previous episodes of catatonia - dates and pertinent developments to social history (as noted above with HPI) with time course and treatment response/failure to ECT or medications
  7. Recent medication changes, with specific focus on timing of symptoms if possible - regimen prior to symptom/sign development, medication changes, and current medication
  8. Neurological conditions - including Traumatic brain injury (TBI), seizure history, neurodevelopmental disorders, delirium, dementia. The Montreal Cognitive Assessment (MOCA) will be administered the day prior to each ECT treatment and the day after each ECT treatment for pre and post procedure cognitive monitoring.
  9. Incontinence
  10. Medical, metabolic, and/or psychiatric comorbidities are recorded but intentionally NOT excluded, with limited exceptions:Cerebrovascular accident (CVA).
  11. Questionnaires and rating scales: The following instruments will be administered by a trained clinician (psychiatric resident, medical student):
  12. Bush- Francis Scale (BFCRS): The BFCRS is a rating scale consisting of 23 catatonia items (Bush et al., 1996a). The first 14 items on this scale are the most common, classical sings of catatonia \& are also known as Catatonia Screening Instrument (BFCSI). If two or more of the BFCSI signs are present, for 24 hours or longer, catatonia is a possibility (Sienaert et al, 2011). For the purpose of this study, a score of 4 or more on the 23-item BCFRS will be considered for inclusion in this study.
  13. Hamilton depression scale
  14. Montreal Cognitive Assessment (MoCA) The administration of the BFCRS, Hamilton depression scale and MoCA will be videotaped for additional rating by a blinded rater. These assessments will be administered before and after each ECT treatment.
  15. Labs and testing to rule out organic causes of catatonia include: EEG electroencephalogram EKG - electrocardiogram CT scan of the head w/o contrast CMP complete metabolic panel, CBC diff complete blood count with differential Thyroid studies TSH T3 T4 Metabolic/Inflammatory laboratory tests (in specific conditions) Urine Analysis with Urine Drug Screen within 48 hours of admission) Fe serum level Fibrin D-dimer Magnesium (Mg)
  16. Pre-anesthesia work-up performed by the department of anesthesia to determine fitness for ECT. Anesthesia faculty will administer anesthesia to participants during the ECT procedure. They will monitor patient in the operating room (OR) before, during and after the ECT procedure for at least 30 minutes for any adverse effects.
  17. ECT treatments will begin after initial evaluation as described above. ECT treatments will be administered three times a week.
  18. Participants will not be required to try and fail a challenge of Intravenous (IV) or Intramuscular (IM) Lorazepam prior to being assigned to receive ECT treatments.
Conditions
Catatonia
Being tested
Electroconvulsive Treatment (ECT) Right Unilateral, Electroconvulsive Treatment (ECT) - Bilateral
Medical subject headings
Catatonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electroconvulsive Treatment (ECT) Right UnilateralDevice

    Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia. Performed unilateral on the right side.

  • Electroconvulsive Treatment (ECT) - BilateralDevice

    Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia. Performed Bilateral.

Study groups in NCT02734498
Study groupRoleWhat they receive
Right unilateral (RUL) ECTActive comparatorRight Unilateral placement of treatment electrodes in electroconvulsive treatment.
Receives: Device: Electroconvulsive Treatment (ECT) Right Unilateral
Bilateral (BL) ECTActive comparatorBilateral placement of treatment electrodes in electroconvulsive treatment.
Receives: Device: Electroconvulsive Treatment (ECT) - Bilateral
Control groupNo interventionNo ECT treatment for control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Catatonia on the Bush- Francis Scale (BFCRS) - Pre

    Repetitive evaluation by the Bush- Francis Scale (BFCRS) - To assess excitement, immobility, mutism, staring, posturing/catalepsy, grimacing, echopraxia, stereotypy, mannerisms, verbigeration, rigidity, negativism, waxy flexibility, withdrawal, impulsivity, automatic obedience, mitgehen, gegenhalten, ambitendency, grasp reflex, preservation, combativeness and automatic abnormality. Contains 23 items rated using a scale of 0-3. Total Score 0-69. Higher scores denote worse outcomes.

    Measured: Prior first ECT treatment

  2. Catatonia on the Bush- Francis Scale (BFCRS) - Pre

    Repetitive evaluation by the Bush- Francis Scale (BFCRS) - To assess excitement, immobility, mutism, staring, posturing/catalepsy, grimacing, echopraxia, stereotypy, mannerisms, verbigeration, rigidity, negativism, waxy flexibility, withdrawal, impulsivity, automatic obedience, mitgehen, gegenhalten, ambitendency, grasp reflex, preservation, combativeness and automatic abnormality. Contains 23 items rated using a scale of 0-3. Total Score 0-69. Higher scores denote worse outcomes.

    Measured: 1 day post first ECT treatment

Secondary outcomes (2)
  1. Depression on the Hamilton Depression Scale

    Repetitive evaluation by the Hamilton depression scale - To measure efficacy of ECT

    Measured: 30 days

  2. Cognitive Side Effects on Montreal Cognitive Assessment (MoCA)

    Repetitive evaluation by the Montreal Cognitive Assessment (MoCA)- To evaluate possible cognitive side effects.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2016 (estimated)
  2. Study startJan 2017
  3. Primary completion19 Mar 2017
  4. Study completion19 Mar 2017

Why it stopped: Unable to enroll

Resources

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02734498
Sponsor's protocol ID
IRB00031669
Status last verified
Jun 2019
First submitted
23 Mar 2016
Last updated
2 Jul 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Personal data of psychiatric patients will not be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Electroconvulsive Treatment (ECT) Right Unilateral and Electroconvulsive Treatment (ECT) - Bilateral in people with Catatonia, run by Wake Forest University Health Sciences 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 2 inclusion and 6 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 2 Jul 2019. 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?

Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Catatonia on the Bush- Francis Scale (BFCRS) - Pre (time frame: Prior first ECT treatment). The study lists 2 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 2 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in