Trial Outcomes & Findings for A Study of the Use of IV Scopolamine to Augment the Efficacy of Electroconvulsive Therapy (ECT) (NCT NCT01312844)

Results Overview

Change in Ham D 17 scores measured by the difference between baseline HAM D score and HAM D score at last ECT administration. The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. A negative change score refers to a decrease in HAM D score, while a positive change score would refer to an increase in HAM D score.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

At the time of ECT completion (about 2 weeks)

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Scopolamine Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Use of IV Scopolamine to Augment the Efficacy of Electroconvulsive Therapy (ECT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Scopolamine n=4 Participants Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=3 Participants Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	48.25 years STANDARD_DEVIATION 8.62 • n=5 Participants	56.67 years STANDARD_DEVIATION 21.78 • n=7 Participants	51.86 years STANDARD_DEVIATION 14.68 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of ECT completion (about 2 weeks)

Change in Ham D 17 scores measured by the difference between baseline HAM D score and HAM D score at last ECT administration. The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. A negative change score refers to a decrease in HAM D score, while a positive change score would refer to an increase in HAM D score.

Outcome measures

Outcome measures
Measure	Scopolamine n=4 Participants Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=3 Participants Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
Change in Ham D 17 Scores	-17.50 units on a scale Standard Deviation 10.47	-14.00 units on a scale Standard Deviation 11.00

PRIMARY outcome

Timeframe: Duration of ECT treatment (usually 2 weeks)

Population: Only 3 (out of 4) Scopolamine patients and 2 (out of 3) placebo patients reached response

The number of days between baseline HAM D score and HAM D score showing response (defined as a HAM D score less than half of baseline). If patients HAM D score rose above this marker at any point in the study, they were not considered as responding.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. .

Outcome measures

Outcome measures
Measure	Scopolamine n=3 Participants Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=2 Participants Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
Time to Response for Patients Receiving ECT	8.33 days Standard Deviation 3.21	5.00 days Standard Deviation 1.41

PRIMARY outcome

Timeframe: Duration of ECTtreatment (usually 2 weeks)

Population: Only 3 (out of 4) Scopolamine patients and 2 (out of 3) placebo patients reached response and remission.

The number of ECT treatments needed to achieve response (defined as a HAM D score less than half of baseline) and remission (defined as a HAM D score of less than 8). If patients HAM D score rose above these markers at any point in the study, they were not considered as responding or remitting.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression.

Outcome measures

Outcome measures
Measure	Scopolamine n=3 Participants Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=2 Participants Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
Number of ECT Treatments Received to Achieve Response/Remission # of ECT administrations to response	2.33 # of ECT administrations Standard Deviation 2.21	2.50 # of ECT administrations Standard Deviation 0.71
Number of ECT Treatments Received to Achieve Response/Remission # of ECT administrations to remission	10.00 # of ECT administrations Standard Deviation 3.46	6.50 # of ECT administrations Standard Deviation 0.71

SECONDARY outcome

Timeframe: Duration of ECT treatment (usually 2 weeks)

The number of ECT treatments withheld during the course of the study due to cognitive impairment. In these cases, the participant would still be enrolled in the study but have a reduced # of ECTs. This outcome measure does not include patients who withdrew from the study.

Outcome measures

Outcome measures
Measure	Scopolamine n=3 Participants Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=3 Participants Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
Number of ECT Treatments Withheld Due to Cognitive Impairment	0 ECT Treatments withheld Standard Deviation 0	0 ECT Treatments withheld Standard Deviation 0

SECONDARY outcome

Timeframe: Duration of ECT treatment (usually 2 weeks)

The mean number of adverse events classified as moderate to severe.

Outcome measures

Outcome measures
Measure	Scopolamine n=4 Participants Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=3 Participants Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
The Mean Number of Moderate to Severe Side Effects	.75 number of side effects Standard Deviation 1.5	0 number of side effects Standard Deviation 0

SECONDARY outcome

Timeframe: Duration of ECT treatment (usually 2 weeks)

Population: Missing vitals forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group

Blood pressure was taken immediately post ECT administration at each ECT visit. We averaged Blood pressure for each participant at each ECT administration. The reported mean refers to the average among all participants in each group.

Outcome measures

Outcome measures
Measure	Scopolamine n=3 Participants Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=3 Participants Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
The Mean Levels of Physiological Measures of ECT (Blood Pressure) Systolic blood pressure immediately post ECT	170.35 mmHg Standard Deviation 37.88	131.05 mmHg Standard Deviation 27.57
The Mean Levels of Physiological Measures of ECT (Blood Pressure) Diastolic Blood Pressure Immediately Post ECT	87.41 mmHg Standard Deviation 16.92	78.80 mmHg Standard Deviation 16.61

SECONDARY outcome

Timeframe: Duration of ECT treatment (usually 2 weeks)

Population: Missing vitals forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group

Heart rate was taken immediately post ECT administration at each ECT visit. We averaged heart rate for each participant at each ECT administration. The reported mean refers to the average among all participants in each group.

Outcome measures

Outcome measures
Measure	Scopolamine n=3 Participants Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=3 Participants Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
The Mean Levels of Physiological Measures of ECT (Heart Rate)	69.24 Beats per minute Standard Deviation 11.45	86.20 Beats per minute Standard Deviation 15.62

SECONDARY outcome

Timeframe: Duration of ECT treatment (usually 2 weeks)

Population: Missing ECT forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group

Mean duration in seconds of the seizure induced by ECT for each participant at each ECT administration they received.The reported mean refers to the average among all participants in each group.

Outcome measures

Outcome measures
Measure	Scopolamine n=3 Participants Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=3 Participants Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
The Mean Levels of Physiological Measures of ECT (Seizure Duration)	30.25 seconds Standard Deviation 7.77	31.89 seconds Standard Deviation 10.56

SECONDARY outcome

Timeframe: Duration of ECT treatment (usually 2 weeks)

Population: Missing ECT forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group

Mean energy needed to induce the seizure for each participant at each ECT administration they received. The reported mean refers to the average among all participants in each group.

Outcome measures

Outcome measures
Measure	Scopolamine n=3 Participants Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=3 Participants Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
The Mean Levels of Physiological Measures of ECT (Energy Needed)	73.83 joules Standard Deviation 31.12	67.06 joules Standard Deviation 30.02

Adverse Events

Scopolamine

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Scopolamine n=4 participants at risk Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=3 participants at risk Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
Nervous system disorders Recent memory loss	25.0% 1/4 • Number of events 1	0.00% 0/3
Psychiatric disorders Agitation requiring restraint	25.0% 1/4 • Number of events 1	0.00% 0/3

Other adverse events

Other adverse events
Measure	Scopolamine n=4 participants at risk Patients receiving IV scopolamine at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT	Placebo n=3 participants at risk Patients receiving IV placebo at ECT treatment Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
Psychiatric disorders Deja vu / confusion	25.0% 1/4 • Number of events 1	0.00% 0/3
Respiratory, thoracic and mediastinal disorders Hypoxia event	0.00% 0/4	33.3% 1/3 • Number of events 1

Additional Information

Dr. John Matthews

Massachusetts General Hospital

Phone: 617-643-9095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place