ClinicalTrials.gg
TerminatedNCT02734498Updated Jul 2, 2019Results posted

Prospective Treatment Study of Catatonia Patients

An interventional study of Electroconvulsive Treatment (ECT) Right Unilateral and Electroconvulsive Treatment (ECT) - Bilateral in Catatonia, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-07-02.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment

Why this study was terminated
Unable to enroll
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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. 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:

A. 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

B. 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.

C. The disturbance is not better explained by another mental disorder

D. the disturbance does not occur exclusively during the course of a delirium

E. 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):

      1. 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.
      2. Hamilton depression scale
      3. 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.

    12. 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)

    13. 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.
    14. ECT treatments will begin after initial evaluation as described above. ECT treatments will be administered three times a week.
    15. 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.
02

Conditions studied

  • Catatonia

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03

In context

Catatonia

22 studies on the registry are indexed under Catatonia; 10 are open to participants now.

This study's enrollment of 2 is below the median of 63 across 14 interventional studies indexed under Catatonia.

Browse Catatonia studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.

Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnant women

Patients with any of the following medical conditions which are for ECT:

  • Pheochromocytoma
  • History of stroke within the past 3 months
  • Cardiac conduction defects
  • Cerebral or aortic aneurysms
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
2 participants (actual)

Study arms

  • Active comparator
    Right unilateral (RUL) ECT

    Right Unilateral placement of treatment electrodes in electroconvulsive treatment.

    Device: Electroconvulsive Treatment (ECT) Right Unilateral

  • Active comparator
    Bilateral (BL) ECT

    Bilateral placement of treatment electrodes in electroconvulsive treatment.

    Device: Electroconvulsive Treatment (ECT) - Bilateral

  • No intervention
    Control group

    No ECT treatment for control group.

Interventions

  • DeviceElectroconvulsive Treatment (ECT) Right Unilateral

    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.

  • DeviceElectroconvulsive Treatment (ECT) - Bilateral

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 1 day post first ECT treatment

Secondary outcomes

  1. Depression on the Hamilton Depression Scale

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

    Time frame: 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.

    Time frame: 30 days

07

Results

Posted Jul 2, 2019
Limitations and caveats
This study was terminated in December 2018 because it was too difficult to enroll. Participants did not complete all the assessments.

Participant flow

Participant flow — Overall Study
MilestoneRight Unilateral (RUL) ECTBilateral (BL) ECTControl Group
Started200
Completed200
Not completed000

Outcome measures

PrimaryCatatonia 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.

Time frame:
Prior first ECT treatment
Reported as:
Mean · units on a scale
Catatonia on the Bush- Francis Scale (BFCRS) - Pre
units on a scaleRight Unilateral (RUL) ECTBilateral (BL) ECTControl Group
Catatonia on the Bush- Francis Scale (BFCRS) - Pre11.5 ± 3.5——
SecondaryDepression on the Hamilton Depression Scale

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

Time frame:
30 days

No measurements were reported for this outcome.

SecondaryCognitive Side Effects on Montreal Cognitive Assessment (MoCA)

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

Time frame:
30 days

No measurements were reported for this outcome.

PrimaryCatatonia 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.

Time frame:
1 day post first ECT treatment
Reported as:
Mean · units on a scale
Catatonia on the Bush- Francis Scale (BFCRS) - Pre
units on a scaleRight Unilateral (RUL) ECTBilateral (BL) ECTControl Group
Catatonia on the Bush- Francis Scale (BFCRS) - Pre5 ± 1——

Adverse events

Collected over AE data collected over a period of 8 days for one patient and a period of 3 days for the other patient during each patient's participation in the study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Right Unilateral (RUL) ECT0/2 (0%)0/2 (0%)0/2 (0%)
Bilateral (BL) ECT———
Control Group———

Baseline characteristics

The study design was too complicated and therefore too difficult to enroll. The study team was unable to continue recruiting because of lack of resources.

Age, Customized
Age, Customized(participants)Right Unilateral (RUL) ECTBilateral (BL) ECTControl GroupTotal
not collected2——2
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Right Unilateral (RUL) ECTBilateral (BL) ECTControl GroupTotal
Not collected2——2
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Right Unilateral (RUL) ECTBilateral (BL) ECTControl GroupTotal
Count of participants———0
Region of Enrollment
Region of Enrollment(participants)Right Unilateral (RUL) ECTBilateral (BL) ECTControl GroupTotal
United States2——2
08

Study locations

1 site
  • Wake Forest University Baptist Medical Center
    Winston-Salem, North Carolina 27104, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Personal data of psychiatric patients will not be shared.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02734498
Responsible party
Sponsor
First posted
Apr 12, 2016
Start date
Jan 2017
Primary completion
Mar 19, 2017
Completion
Mar 19, 2017
Results posted
Jul 2, 2019
Last update
Jul 2, 2019

Study contacts

James Kimball, M.D
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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