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
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.
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:
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).
Prior to treatment each patient will be examined by a clinician (psychiatrist and psychiatric resident) in which the following information will be obtained:
Questionnaires and rating scales: The following instruments will be administered by a trained clinician (psychiatric resident, medical student):
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.
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)
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 →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.
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.
Exclusion Criteria:
Patients with any of the following medical conditions which are for ECT:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Right Unilateral placement of treatment electrodes in electroconvulsive treatment.
Device: Electroconvulsive Treatment (ECT) Right Unilateral
Bilateral placement of treatment electrodes in electroconvulsive treatment.
Device: Electroconvulsive Treatment (ECT) - Bilateral
No ECT treatment for control group.
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.
Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia. Performed Bilateral.
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
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
Depression on the Hamilton Depression Scale
Repetitive evaluation by the Hamilton depression scale - To measure efficacy of ECT
Time frame: 30 days
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
| Milestone | Right Unilateral (RUL) ECT | Bilateral (BL) ECT | Control Group |
|---|---|---|---|
| Started | 2 | 0 | 0 |
| Completed | 2 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
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.
| units on a scale | Right Unilateral (RUL) ECT | Bilateral (BL) ECT | Control Group |
|---|---|---|---|
| Catatonia on the Bush- Francis Scale (BFCRS) - Pre | 11.5 ± 3.5 | — | — |
Repetitive evaluation by the Hamilton depression scale - To measure efficacy of ECT
No measurements were reported for this outcome.
Repetitive evaluation by the Montreal Cognitive Assessment (MoCA)- To evaluate possible cognitive side effects.
No measurements were reported for this outcome.
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.
| units on a scale | Right Unilateral (RUL) ECT | Bilateral (BL) ECT | Control Group |
|---|---|---|---|
| Catatonia on the Bush- Francis Scale (BFCRS) - Pre | 5 ± 1 | — | — |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Right Unilateral (RUL) ECT | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Bilateral (BL) ECT | — | — | — |
| Control Group | — | — | — |
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(participants) | Right Unilateral (RUL) ECT | Bilateral (BL) ECT | Control Group | Total |
|---|---|---|---|---|
| not collected | 2 | — | — | 2 |
| Sex/Gender, Customized(Participants) | Right Unilateral (RUL) ECT | Bilateral (BL) ECT | Control Group | Total |
|---|---|---|---|---|
| Not collected | 2 | — | — | 2 |
| Race and Ethnicity Not Collected(Participants) | Right Unilateral (RUL) ECT | Bilateral (BL) ECT | Control Group | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Right Unilateral (RUL) ECT | Bilateral (BL) ECT | Control Group | Total |
|---|---|---|---|---|
| United States | 2 | — | — | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Personal data of psychiatric patients will not be shared.
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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