Trial Outcomes & Findings for Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression (NCT NCT01907217)
NCT ID: NCT01907217
Last Updated: 2018-11-14
Results Overview
The HDRS was originally designed to assess severity of depressive symptoms in patients with a primary depressive illness and is now the most commonly used measure of depression severity. It was first published in a 17-item format with the optional addition of 4 items making up the 21-item version. In addition to the original 21 items, the 24-item HDRS includes items on helplessness, hopelessness and worthlessness; its score range is 0-77, with higher scores reflecting greater burden of depressive symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
138 participants
Primary outcome timeframe
HDRS scores were obtained at baseline, end of allocated ECT treatment, and at 3 and 6 month follow-up timepoints.
Results posted on
2018-11-14
Participant Flow
Participant milestones
| Measure |
Bilateral ECT Mecta 5000M
Twice-weekly modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
High-dose Unilateral ECT Mecta 5000M
Twice-weekly high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
69
|
|
Overall Study
COMPLETED
|
69
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Bilateral ECT Mecta 5000M
Twice-weekly modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
High-dose Unilateral ECT Mecta 5000M
Twice-weekly high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression
Baseline characteristics by cohort
| Measure |
Bilateral ECT Mecta 5000M
n=69 Participants
Twice-weekly modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
High-dose Unilateral ECT Mecta 5000M
n=69 Participants
Twice-weekly high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
69 participants
n=5 Participants
|
69 participants
n=7 Participants
|
138 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: HDRS scores were obtained at baseline, end of allocated ECT treatment, and at 3 and 6 month follow-up timepoints.Population: Intention to treat analysis.
The HDRS was originally designed to assess severity of depressive symptoms in patients with a primary depressive illness and is now the most commonly used measure of depression severity. It was first published in a 17-item format with the optional addition of 4 items making up the 21-item version. In addition to the original 21 items, the 24-item HDRS includes items on helplessness, hopelessness and worthlessness; its score range is 0-77, with higher scores reflecting greater burden of depressive symptoms.
Outcome measures
| Measure |
Bilateral ECT Mecta 5000M
n=69 Participants
Modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure duration is measured by EEG monitoring. Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
High-dose Unilateral ECT Mecta 5000M
n=69 Participants
Modified high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HDRS)
Baseline
|
29.5 units on a scale
Standard Deviation 6.3
|
30.4 units on a scale
Standard Deviation 6.1
|
|
Hamilton Depression Rating Scale (HDRS)
End-of-treatment
|
12.5 units on a scale
Standard Deviation 9.2
|
11.1 units on a scale
Standard Deviation 7.5
|
|
Hamilton Depression Rating Scale (HDRS)
3 months follow-up
|
15.0 units on a scale
Standard Deviation 10.2
|
11.5 units on a scale
Standard Deviation 9.1
|
|
Hamilton Depression Rating Scale (HDRS)
6 months follow-up
|
13.0 units on a scale
Standard Deviation 8.6
|
12.6 units on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: end of allocated ECT coursePopulation: Not all patients completed this cognitive task.
The AMI-SF is used to assess retrospective autobiographical memory function. It has six categories, which involve five questions each, about a family member, most recent travel, last New Year's Eve, last birthday, most recent employment and last visit to a doctor for a physical complaint. At baseline interviewers encourage the participant to recall as much information as they can. Responses at baseline can be scored either two points, for a recognisable real memory, or zero for no memory or too little information to constitute a proper memory. Only those questions for which a memory had been retrieved at baseline are examined at follow-up. Follow-up assessments are scored as percentage recall of baseline score, which is scored as 100% irrespective of actual performance..
Outcome measures
| Measure |
Bilateral ECT Mecta 5000M
n=64 Participants
Modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure duration is measured by EEG monitoring. Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
High-dose Unilateral ECT Mecta 5000M
n=64 Participants
Modified high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
|---|---|---|
|
Columbia Autobiographical Memory Interview-Short Form (AMI-SF)
|
56.8 % of baseline performance
Standard Deviation 17.3
|
67.1 % of baseline performance
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: 3 months follow-upPopulation: Not all patients completed this cognitive task.
The AMI-SF is used to assess retrospective autobiographical memory function. It has six categories, which involve five questions each, about a family member, most recent travel, last New Year's Eve, last birthday, most recent employment and last visit to a doctor for a physical complaint. At baseline interviewers encourage the participant to recall as much information as they can. Responses at baseline can be scored either two points, for a recognisable real memory, or zero for no memory or too little information to constitute a proper memory. Only those questions for which a memory had been retrieved at baseline are examined at follow-up. Follow-up assessments are scored as percentage recall of baseline score, which is scored as 100% irrespective of actual performance..
Outcome measures
| Measure |
Bilateral ECT Mecta 5000M
n=48 Participants
Modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure duration is measured by EEG monitoring. Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
High-dose Unilateral ECT Mecta 5000M
n=56 Participants
Modified high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
|---|---|---|
|
Columbia Autobiographical Memory Interview-Short Form (AMI-SF)
|
56.2 % of baseline performance
Standard Deviation 18.1
|
67.3 % of baseline performance
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: 6 months follow-upPopulation: Not all patients completed this cognitive task.
The AMI-SF is used to assess retrospective autobiographical memory function. It has six categories, which involve five questions each, about a family member, most recent travel, last New Year's Eve, last birthday, most recent employment and last visit to a doctor for a physical complaint. At baseline interviewers encourage the participant to recall as much information as they can. Responses at baseline can be scored either two points, for a recognisable real memory, or zero for no memory or too little information to constitute a proper memory. Only those questions for which a memory had been retrieved at baseline are examined at follow-up. Follow-up assessments are scored as percentage recall of baseline score, which is scored as 100% irrespective of actual performance..
Outcome measures
| Measure |
Bilateral ECT Mecta 5000M
n=42 Participants
Modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure duration is measured by EEG monitoring. Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
High-dose Unilateral ECT Mecta 5000M
n=49 Participants
Modified high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
|---|---|---|
|
Columbia Autobiographical Memory Interview-Short Form (AMI-SF)
|
52.9 % of baseline performance
Standard Deviation 16.4
|
63.4 % of baseline performance
Standard Deviation 17.7
|
Adverse Events
Bilateral ECT Mecta 5000M
Serious events: 9 serious events
Other events: 33 other events
Deaths: 0 deaths
High-dose Unilateral ECT Mecta 5000M
Serious events: 7 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bilateral ECT Mecta 5000M
n=69 participants at risk
Twice-weekly modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
High-dose Unilateral ECT Mecta 5000M
n=69 participants at risk
Twice-weekly high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
|---|---|---|
|
Cardiac disorders
ECT-related hypertension
|
2.9%
2/69 • Number of events 2 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
5.8%
4/69 • Number of events 4 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
laryngospasm
|
0.00%
0/69 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
1.4%
1/69 • Number of events 1 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
|
Cardiac disorders
tachyarrhythmia
|
1.4%
1/69 • Number of events 1 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
1.4%
1/69 • Number of events 1 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
|
Psychiatric disorders
attempted suicide
|
0.00%
0/69 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
1.4%
1/69 • Number of events 1 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
|
Nervous system disorders
interictal confusion
|
4.3%
3/69 • Number of events 3 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
0.00%
0/69 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.4%
1/69 • Number of events 1 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
0.00%
0/69 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
|
Cardiac disorders
bradyarrhythmia
|
1.4%
1/69 • Number of events 1 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
0.00%
0/69 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolus
|
1.4%
1/69 • Number of events 1 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
0.00%
0/69 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
Other adverse events
| Measure |
Bilateral ECT Mecta 5000M
n=69 participants at risk
Twice-weekly modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
High-dose Unilateral ECT Mecta 5000M
n=69 participants at risk
Twice-weekly high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
27.5%
19/69 • Number of events 19 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
26.1%
18/69 • Number of events 18 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
|
Gastrointestinal disorders
nausea
|
11.6%
8/69 • Number of events 8 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
15.9%
11/69 • Number of events 11 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
8.7%
6/69 • Number of events 6 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
11.6%
8/69 • Number of events 8 • Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
|
Additional Information
Prof Declan McLoughlin
St Patrick's University Hospital
Phone: +353 1 2493343
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place