Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05923476 |
| Other study ID # |
HREC/69072/MH-2021 |
| Secondary ID |
ID: 2021-03 |
| Status |
Active, not recruiting |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
June 2023 |
| Source |
Melbourne Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Depression is a major psychiatric illness associated with significant morbidity and
mortality. Electroconvulsive therapy (ECT) is the most effective treatment for depression and
arguably the safest. However, a sizable proportion of patients (20%-30%) do not get well with
ECT. Typically, ECT is given as a course extending over weeks and then discontinued.
Approximately 50% of patients become unwell again in one year after the completion of ECT
even when they use antidepressant medications. Moreover, ECT brings recovery after a series
of treatment sessions, usually with a range of 6-20. Each ECT session poses logistic issues.
Lithium has robust antidepressant effect when used with antidepressant medications. A
combination of lithium and ECT has been studied previously in mania and found to be safe at a
lithium level in the human body below 0.6 mEq/L. There is a gap in the literature about the
use of lithium and ECT combination in depression. This pilot study aims to investigate the
feasibility and safety of conducting a randomized controlled trial comparing lithium and ECT
against placebo and ECT. Participants will have either placebo and ECT or lithium ECT at an
equal probability. They will be approached for an expression of interest, invited to take
part in a consenting session, screened for the eligibility for the study, and assessed for
the severity of depression, and cognitive function and then for the improvement in
depression. Lithium blood level will be monitored five days after commencement of lithium and
each dose change. Participants will be assessed for adverse reactions after each ECT using a
formal adverse monitoring report form. Recruitment numbers, trial retention and completion
rates and adverse events will be reported.
Description:
Title: Electroconvulsive therapy and concomitant lithium in depressive disorder Short Title:
ECT and lithium in depression Design: Randomized Controlled Trial-Pilot Study Study Centres:
North-Western Mental Health, Hospital: Sunshine Hospital Study Questions: Is a combination of
lithium and electroconvulsive therapy (ECT) safe compared with placebo and ECT in patients
with a depressive disorder and can this combination be tested in a randomized controlled
trial? Study Objectives: To demonstrate the feasibility and safety of conducting a randomized
controlled trial of lithium and electroconvulsive therapy against placebo and
electroconvulsive therapy.
Inclusion Criteria:
- A depressive episode either in the context of Major Depressive Disorder or bipolar
disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, DSM-V,
criteria.
- Hamilton Rating Scale for Depression (HRSD 28-item) score of 18 or more.
- Participants who were prescribed ECT as part of standard care.
- Provides written informed consent.
Exclusion Criteria:
- Age below 18 years.
- Contraindication for lithium: renal dysfunction; cardiac disease; concomitant
nonsteroidal anti-inflammatory drugs, angiotensin inhibitors and diuretics.
- Neurocognitive disorder (dementia) as defined by DSM-V criteria.
- Serious medical conditions that may preclude ECT or lithium.
- Current or history of non-mood disorder psychosis.
- Pregnancy and lactation based on clinical history and urine pregnancy test.
- A previous history of adverse events to lithium or previous history of lithium toxicity.
Number of Planned Participants:
10 participants in the lithium + ECT group and 10 participants in placebo +ECT group.
Study duration: Two years Investigational product: Lithium
Statistical Methods:
Outcomes Baseline demographic characteristics and variables will be reported with descriptive
statistics, mean (SD) or median (25th - 75th percentiles) for continuous variables and
frequency (%) for categorical variables.
The number of participants recruited, and their retention rate and the incidence of adverse
effects to lithium will be reported. These variables include the severity of depression, the
presence of psychotic symptoms, number of previous episodes, the duration of current illness,
age, gender, education, socioeconomic status, substance abuse, current medications, and
psychiatric and medical comorbidities. Since this is a feasibility study no inferential
statistics is planned.
Primary outcome The primary outcome is feasibility as defined as the number of participants
who were recruited and randomized and assessed and who received the interventions and
remained in the study until completion.
Secondary outcomes
Safety outcomes:
1. Adverse reactions to lithium as defined by
- Increased rate of post-ECT delirium as measured by time taken for reorientation
longer than 30 minutes and defined as DSM-V criteria for delirium.
- Prolonged seizure, defined as a seizure continuously longer than 120 seconds.
- Prolonged apnea, defined as apnea longer than 5 minutes.
2. Incidence of lithium toxicity as defined as clinical symptoms and signs which include
coarse tremor, disorientation, ataxia (indicating cerebellar involvement) and myoclonus
in conjunction with the lithium level above 1.1 mEq/L. If the above symptoms and signs
temporally correlated with lithium administration, they will be taken as lithium
toxicity even if the lithium level is below 1.1 mEq/L. The study will closely monitor
for early warning symptoms and signs, viz., general weakness, diarrhoea, vomiting, a
change in the pattern of lithium induced tremor, disorientation and attentional
impairment. These early warning symptoms will be treated as lithium manifestations of
lithium toxicity in conjunction with a lithium level above 1.1 MeQ/L.
3. Response as defined by 60% reduction or more on HDRS score.
- The proportion with response (95% CI) will be reported.
- The speed of remission/response as defined by the number of ECT required. The mean
number of treatments (with SD) will be reported.
- The cognitive outcome, as measured by MoCA and CAMI. The mean scores with SD will
be reported.
Since this is a pilot study no inferential statistics is planned. Subgroups: None Consumer
Involvement Consumer and carer representatives will provide general support to participants
within the scope of their practice. However, they will not be involved in the specific
aspects of the study such as recruitment.
