Trial Outcomes & Findings for Preventing Relapse After Successful Electroconvulsive Therapy for Depression (NCT NCT06751875)
NCT ID: NCT06751875
Last Updated: 2026-05-05
Results Overview
The investigators will compare the lithium-arm with the arm without lithium, as we look at the relapse rate and depression severity. Relapse rate was described as the percentage of patients in each of the two treatment arms that relapsed. Depression severity was measured using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C), a 30-item clinician-rated scale assessing the severity of depressive symptoms. Because only one of two 'appetite disturbance/body weight disturbance' items are selected for rating, the score of 28 items is added to reach a final score. Each item is scored 0-3, resulting in a total score range of 0-84, where higher scores indicate more severe depression.
COMPLETED
NA
96 participants
Start of Maintenance Phase with repeated assessments at fixed points for six months (1 month, 2 month, 3 month, 4 month, 5 month, and 6 month) during the maintenance period through 6-month follow-up.
2026-05-05
Participant Flow
Ninety-six patients (63.9%) entered the Maintenance Phase of the study and were randomized to either the lithium (n=50) or non-lithium (n=46) group. During the Follow-up Phase, 60 patients were followed, and 50 completed the full trial. Patients were recruited across the four sites: UPC Duffel (n=37, 38.5%), UPC KU Leuven (n=27, 28.1%), AZ Sint-Brugge (n=23, 24%) and Erasmus MC Rotterdam (n=9, 9.4%).
Participant milestones
| Measure |
Lithium Arm
STABLE-M-ECT + M-Pharm, with lithium augmentation.
|
Non-Lithium Arm
STABLE-M-ECT + M-Pharm, without lithium augmentation.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
46
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
24
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lithium Arm
n=50 Participants
STABLE-M-ECT + M-Pharm, with lithium augmentation.
|
Non-Lithium Arm
n=46 Participants
STABLE-M-ECT + M-Pharm, without lithium augmentation.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
20 Participants
n=50 Participants
|
16 Participants
n=46 Participants
|
36 Participants
n=96 Participants
|
|
Number of depressive episodes in history
|
2.3 Episodes
STANDARD_DEVIATION 2 • n=50 Participants
|
2 Episodes
STANDARD_DEVIATION 2.1 • n=46 Participants
|
2.2 Episodes
STANDARD_DEVIATION 2 • n=96 Participants
|
|
Age, Continuous
|
57.9 Years
STANDARD_DEVIATION 12.2 • n=50 Participants
|
61.6 Years
STANDARD_DEVIATION 13.2 • n=46 Participants
|
59.8 Years
STANDARD_DEVIATION 12.8 • n=96 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=50 Participants
|
30 Participants
n=46 Participants
|
60 Participants
n=96 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Start of Maintenance Phase with repeated assessments at fixed points for six months (1 month, 2 month, 3 month, 4 month, 5 month, and 6 month) during the maintenance period through 6-month follow-up.The investigators will compare the lithium-arm with the arm without lithium, as we look at the relapse rate and depression severity. Relapse rate was described as the percentage of patients in each of the two treatment arms that relapsed. Depression severity was measured using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C), a 30-item clinician-rated scale assessing the severity of depressive symptoms. Because only one of two 'appetite disturbance/body weight disturbance' items are selected for rating, the score of 28 items is added to reach a final score. Each item is scored 0-3, resulting in a total score range of 0-84, where higher scores indicate more severe depression.
Outcome measures
| Measure |
Lithium Arm
n=50 Participants
STABLE-M-ECT + M-Pharm, with lithium augmentation.
|
Non-Lithium Arm
n=46 Participants
STABLE-M-ECT + M-Pharm, without lithium augmentation.
|
|---|---|---|
|
Relapse Rate
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Five monthly assessments at 2, 3, 4, 5, and 6 months during the Maintenance Phase (modeled as one value).Population: All participants with IDS-C ≥ 29 at baseline, from both the lithium and non-lithium arm, who completed at least one follow-up assessment were included.
Depression severity was measured using two scales: the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C), a 30-item clinician-rated scale assessing the severity of depressive symptoms and the Inventory of Depressive Symptomatology - Self Rated (IDS-SR), a 30-item self-report version assessing the same depressive symptoms from the participant's perspective. Because only one of two 'appetite disturbance/body weight disturbance' items are selected for rating, the score of 28 items is added to reach a final score. Each item is scored 0-3, resulting in a total score range of 0-84, where higher scores indicate more severe depression. These total scores were subsequently used as variables in a mixed-effects model to examine changes in depression severity over time and to compare clinician-rated and self-rated assessments. All timepoints were modeled simultaneously, allowing estimation of their joint effects into one single value rather than analyzing each timepoint separately.
Outcome measures
| Measure |
Lithium Arm
n=50 Participants
STABLE-M-ECT + M-Pharm, with lithium augmentation.
|
Non-Lithium Arm
n=46 Participants
STABLE-M-ECT + M-Pharm, without lithium augmentation.
|
|---|---|---|
|
Depression Severity Differences
|
42.7 IDS-C depression severity score
Standard Deviation 8.2
|
41.3 IDS-C depression severity score
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Start of Maintenance Phase, timepoint at month 1.The investigators will compare the lithium arm with the arm without lithium to evaluate neurocognitive function, as measured by the Montreal Cognitive Assessment (MoCA), which assesses multiple cognitive domains including memory, attention, executive function, language, visuospatial skills, and orientation. Standard MoCA cut-off scores will be used to interpret cognitive impairment. Cut-off scores are 26 or above (out of 30)=normal, 18-25=Mild Cognitive Impairment, 10-17=Moderate Cognitive Impairment \& Below 10=Severe Cognitive Impairment.
Outcome measures
| Measure |
Lithium Arm
n=50 Participants
STABLE-M-ECT + M-Pharm, with lithium augmentation.
|
Non-Lithium Arm
n=46 Participants
STABLE-M-ECT + M-Pharm, without lithium augmentation.
|
|---|---|---|
|
Cognitive Performance
|
23.8 Score on a scale
Standard Deviation 3.2
|
23.1 Score on a scale
Standard Deviation 3.5
|
Adverse Events
Lithium Arm
Non-Lithium Arm
Serious adverse events
| Measure |
Lithium Arm
n=50 participants at risk
STABLE-M-ECT + M-Pharm, with lithium augmentation.
|
Non-Lithium Arm
n=46 participants at risk
STABLE-M-ECT + M-Pharm, without lithium augmentation.
|
|---|---|---|
|
Cardiac disorders
cardial arrythmia, needing hospitalisation
|
0.00%
0/50 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
2.2%
1/46 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
|
Psychiatric disorders
suicide attempt during study follow-up
|
0.00%
0/50 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
2.2%
1/46 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
Other adverse events
| Measure |
Lithium Arm
n=50 participants at risk
STABLE-M-ECT + M-Pharm, with lithium augmentation.
|
Non-Lithium Arm
n=46 participants at risk
STABLE-M-ECT + M-Pharm, without lithium augmentation.
|
|---|---|---|
|
Nervous system disorders
memory complaints
|
10.0%
5/50 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
8.7%
4/46 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
|
Nervous system disorders
tremor to both hands
|
6.0%
3/50 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
4.3%
2/46 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
|
Nervous system disorders
headache
|
4.0%
2/50 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
4.3%
2/46 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
|
Cardiac disorders
elevation of blood pressure
|
0.00%
0/50 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
6.5%
3/46 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
|
Infections and infestations
COVID infection
|
6.0%
3/50 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
4.3%
2/46 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
|
Renal and urinary disorders
renal hypofunction
|
2.0%
1/50 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
0.00%
0/46 • From enrollment until end of follow-up, up to 1 month after last test visit.
AE: any undesirable experience occurring to a subject during the study, whether or not considered related to treatment with antidepressants, ECT or Lithium. All adverse events reported spontaneously by the subject or observed by one of the investigators will be recorded SAE: any medical occurrence or effect that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability or incapacity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place