Prospective Treatment Study of Catatonia Patients

NCT ID: NCT02734498

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-03-19

Brief 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.

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.

Conditions

Catatonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Right unilateral (RUL) ECT

Right Unilateral placement of treatment electrodes in electroconvulsive treatment.

Group Type: ACTIVE_COMPARATOR

Electroconvulsive Treatment (ECT) Right Unilateral

Intervention Type: DEVICE

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.

Bilateral (BL) ECT

Bilateral placement of treatment electrodes in electroconvulsive treatment.

Group Type: ACTIVE_COMPARATOR

Electroconvulsive Treatment (ECT) - Bilateral

Intervention Type: DEVICE

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

Control group

No ECT treatment for control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Electroconvulsive 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.

Intervention Type: DEVICE

Electroconvulsive Treatment (ECT) - Bilateral

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Kimball, M.D

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00031669

Identifier Type: -

Identifier Source: org_study_id