Prospective Treatment Study of Catatonia Patients

NCT02734498 | Terminated Results FDA Device

• 1 other identifier: IRB00031669
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Catatonia

Outcome Measures

Primary Outcomes (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.

  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.

  1 day post first ECT treatment

Secondary Outcomes (2)

• Depression on the Hamilton Depression Scale

  30 days

• Cognitive Side Effects on Montreal Cognitive Assessment (MoCA)

  30 days

Study Arms (3)

Right unilateral (RUL) ECT

ACTIVE COMPARATOR

Right Unilateral placement of treatment electrodes in electroconvulsive treatment.

Device: Electroconvulsive Treatment (ECT) Right Unilateral

Bilateral (BL) ECT

ACTIVE COMPARATOR

Bilateral placement of treatment electrodes in electroconvulsive treatment.

Device: Electroconvulsive Treatment (ECT) - Bilateral

Control group

NO INTERVENTION

No ECT treatment for control group.

Interventions

Electroconvulsive Treatment (ECT) Right Unilateral 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.

Right unilateral (RUL) ECT

Electroconvulsive Treatment (ECT) - Bilateral DEVICE

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

Bilateral (BL) ECT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Catatonia

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Limitations and Caveats

This study was terminated in December 2018 because it was too difficult to enroll. Participants did not complete all the assessments.

Results Point of Contact

• Title: James Kimball, MD
• Organization: Wake Forest School of Medicine

jkimball@wakehealth.edu

336-716-9702

Study Officials

• James Kimball, M.D

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 12, 2016
• Study Start: January 1, 2017
• Primary Completion: March 19, 2017
• Study Completion: March 19, 2017
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)