Prospective Treatment Study of Catatonia Patients

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.

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:

- 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