Prolonging Remission in Depressed Elderly (PRIDE)

Study Overview
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Brief Summary
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This study will determine whether medications alone or medications and electroconvulsive therapy (ECT) work best to prevent depressive relapse and to improve quality of life for older people with severe mood disorders.

Detailed Description
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While advances have been made in the acute treatment of geriatric depression, failure to maintain remission following successful treatment remains a major public health problem. In particular, loss of antidepressant response can result in ongoing functional impairment and increased risk of suicide. This is especially salient for severe and/or treatment resistant illness, even after successful ECT. This trial builds upon the work of the Consortium for Research in Electroconvulsive Therapy (CORE) group that showed that continuation ECT and combination pharmacotherapy were equally effective in preventing relapse following response to acute ECT. We are now testing whether combined pharmacotherapy and ECT, individualized according to patient response, will be more effective in maintaining remission in depressed older adults than pharmacotherapy alone. Moving beyond the traditional fixed schedule for continuation ECT, we are introducing a novel Symptom-Titrated Algorithm-Based Longitudinal ECT (STABLE) regimen. The STABLE algorithm ensures that the timing of ECT treatments is based upon clinical need, helping to achieve the dual goals of adequately treating people showing early signs of symptom re-emergence, while preventing the over-treatment of patients who may be in a stable remission. The continuation therapy usual care comparator arm is the combination pharmacotherapy of Li plus VLF (PHARM). At 7 sites, 322 patients will receive an acute course of right unilateral (RUL) ECT augmented by standardized medication (Phase I); 188 remitters are randomly assigned to one of the 2 groups and followed for 6 months (Phase II). To balance the amount of clinical contact, the schedule of clinic and telephone ratings will be identical for patients in both the PHARM and STABLE arms. For both groups, relapse is defined as Hamilton Rating Scale for Depression-24 (HRSD24) scores >21 at two consecutive time points, suicidality, or psychiatric hospitalization.

Official Title
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Prolonging Remission in Depressed Elderly (PRIDE)

Conditions
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Depression

Intervention / Treatment
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* Drug: lithium and Venlafaxine
* Procedure: ECT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV diagnosis of major depressive episode, unipolar, based on the Mini-International Neuropsychiatric Interview (M.I.N.I) for DSM-IV ECT is clinically indicated Exclusion Criteria: Lifetime history of bipolar affective disorder, schizophrenia, schizoaffective disorder, or mental retardation Current diagnosis of delirium, dementia, or substance abuse/dependence in past 6 months as defined by DSM-IV-TR criteria

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PHARM<br>lithium and venlafaxine | Drug: lithium and Venlafaxine<br>* Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l<br>|
| Experimental: STABLE<br>ECT + VLF + Li | Procedure: ECT<br>* Procedure: ECT RUL ultra brief pulse ECT, 4 treatments in one month and then treatment on an as-needed basis for 5 months Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at every week | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 2 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 4 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured by a telephone interview at week 5 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 6 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured by a telephone interview at week 7 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 8 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured by a telephone interview at week 9 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 10 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured by a telephone interview at week 11 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 12 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured by a telephone interview at week 13 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 14 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured by a telephone interview at week 15 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 16 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured by a telephone interview at week 17 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 18 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured by a telephone interview at week 19 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 20 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured by a telephone interview at week 21 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 22 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured by a telephone interview at week 23 | 
| Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) | Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 | Measured at clinic visits at week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of functioning (SF-36) | Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at baseline | 
| Level of functioning (SF-36) | Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 4 | 
| Level of functioning (SF-36) | Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 8 | 
| Level of functioning (SF-36) | Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 12 | 
| Level of functioning (SF-36) | Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 16 | 
| Level of functioning (SF-36) | Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 20 | 
| Level of functioning (SF-36) | Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 24 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at baseline | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 2 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 4 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 8 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 10 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 12 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 14 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 16 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 18 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 20 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 22 | 
| Tolerability (Mini Mental State Examination [MMSE]) | Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 24 | 
| Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) | Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at baseline | 
| Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) | Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 4 | 
| Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) | Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 8 | 
| Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) | Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 12 | 
| Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) | Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 16 | 
| Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) | Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 20 | 
| Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) | Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24 | Measured at week 24 | 
| Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency | Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24 | Measured at baseline | 
| Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency | Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24 | Measured at weeks 12 | 
| Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency | Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24 | Measured at weeks 24 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at baseline | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 2 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 4 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 6 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 8 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 10 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 12 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 14 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 16 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 18 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 20 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 22 | 
| Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) | Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Measured at week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, ECT, electroconvulsive therapy, mood disorders, continuation ECT, continuation pharmacotherapy, geriatric, elderly, lithium, venlafaxine