Trial Outcomes & Findings for Prospective Treatment Study of Catatonia Patients (NCT NCT02734498)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Prior first ECT treatment

Results posted on

2019-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Right Unilateral (RUL) ECT Right Unilateral placement of treatment electrodes in electroconvulsive treatment. Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia	Bilateral (BL) ECT Bilateral placement of treatment electrodes in electroconvulsive treatment. Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia	Control Group No ECT treatment for control group.
Overall Study STARTED	2	0	0
Overall Study COMPLETED	2	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Right Unilateral (RUL) ECT n=2 Participants Right Unilateral placement of treatment electrodes in electroconvulsive treatment. Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia	Bilateral (BL) ECT Bilateral placement of treatment electrodes in electroconvulsive treatment. Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia	Control Group No ECT treatment for control group.	Total n=2 Participants Total of all reporting groups
Age, Customized not collected	2 participants n=2 Participants	—	—	2 participants n=2 Participants
Sex/Gender, Customized Not collected	2 Participants n=2 Participants	—	—	2 Participants n=2 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	2 participants n=2 Participants	—	—	2 participants n=2 Participants

PRIMARY outcome

Timeframe: Prior first ECT treatment

Population: Only two participants enrolled because study ended. Both randomized to same group.

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.

Outcome measures

Outcome measures
Measure	Right Unilateral (RUL) ECT n=2 Participants Right Unilateral placement of treatment electrodes in electroconvulsive treatment. Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia	Bilateral (BL) ECT Bilateral placement of treatment electrodes in electroconvulsive treatment. Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia	Control Group No ECT treatment for control group.
Catatonia on the Bush- Francis Scale (BFCRS) - Pre	11.5 units on a scale Standard Deviation 3.5	—	—

PRIMARY outcome

Timeframe: 1 day post first ECT treatment

Population: Only two participants enrolled because study ended. Both randomized to same group.

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.

Outcome measures

Outcome measures
Measure	Right Unilateral (RUL) ECT n=2 Participants Right Unilateral placement of treatment electrodes in electroconvulsive treatment. Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia	Bilateral (BL) ECT Bilateral placement of treatment electrodes in electroconvulsive treatment. Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia	Control Group No ECT treatment for control group.
Catatonia on the Bush- Francis Scale (BFCRS) - Pre	5 units on a scale Standard Deviation 1	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Data not collected

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: Data not collected

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

Outcome measures

Outcome data not reported

Adverse Events

Right Unilateral (RUL) ECT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bilateral (BL) ECT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Kimball, MD

Wake Forest School of Medicine

Phone: 336-716-9702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place