Treatment-Resistant Bipolar Depression: A Randomized Controlled Trial of Electroconvulsive Therapy Versus Algorithm-Based Pharmacological Treatment
Abstract
Objective:
Method:
Results:
Conclusion:
Method
Overview
Subjects
Treatments
Electroconvulsive therapy.
Algorithm-based pharmacological treatment.
Randomization and Masking of Study Groups
Assessments
Outcome Measures
Ethics
Statistics
Descriptive analyses.
Missing data.
Efficacy analyses.
Results
Patient Flow and Characteristics
Measure | ECT (N=38) | Algorithm-Based Pharmacological Treatment (N=35) | Analysis | ||||
---|---|---|---|---|---|---|---|
Mean | SD | Mean | SD | t | df | p | |
Age at study inclusion (years) | 48.0 | 10.1 | 48.4 | 13.2 | 0.16 | 71 | 0.88 |
Age at illness onset (years) | 15.9 | 6.7 | 19.0 | 11.3 | 1.34 | 47.3 | 0.19 |
Duration of illness (years) | 31.8 | 12.2 | 27.7 | 10.6 | –1.45 | 65 | 0.16 |
Number of episodes | |||||||
Depressive | 22.3 | 24.2 | 17.4 | 14.1 | –0.94 | 57 | 0.36 |
Hypomanic | 18.2 | 30.8 | 9.6 | 8.1 | –1.51 | 36.2 | 0.14 |
Manic | 2.7 | 8.6 | 1.1 | 2.6 | –0.94 | 58 | 0.36 |
Psychotic | 1.6 | 2.7 | 3.3 | 9.7 | 1.00 | 60 | 0.33 |
Scores on rating scales | |||||||
Montgomery-Åsberg Depression Rating Scalea | 39.1 | 7.5 | 38.0 | 7.4 | –0.60 | 71 | 0.55 |
30-item Inventory of Depressive Symptomatology–Clinician-Ratedb | 48.9 | 9.7 | 46.5 | 13.6 | –0.83 | 64 | 0.41 |
Young Mania Rating Scalec | 3.5 | 2.8 | 3.2 | 2.3 | –0.55 | 71 | 0.59 |
Clinical Global Impression for Bipolar Disorderd | 5.8 | 0.7 | 5.8 | 0.7 | –0.48 | 68 | 0.64 |
N | % | N | % | χ2 | df | p | |
Male gender | 21 | 55.3 | 16 | 45.7 | 0.67 | 1 | 0.42 |
Bipolar disorder type I | 14 | 36.8 | 15 | 42.9 | 0.28 | 1 | 0.60 |
Lifetime medication use | |||||||
Antipsychotics | 30 | 78.9 | 30 | 87.5 | 0.57 | 1 | 0.55 |
Antidepressants | 35 | 92.1 | 33 | 94.3 | 0.14 | 1 | 1.00 |
Anticonvulsants | 33 | 86.8 | 25 | 71.4 | 2.65 | 1 | 0.15 |
Lithium | 12 | 31.6 | 20 | 51.7 | 4.84 | 1 | 0.04 |
Treatment Variables
Patient | Lithium: Mean Dosage (mg/day)a | Anticonvulsants, With Mean Dosage (mg/day)b | Antipsychotics, With Mean Dosage (mg/day) | Antidepressants (Classc), With Mean Daily Dosage (mg/day) | Time of Study Exit (week) | MADRSd Score at Study Exit |
---|---|---|---|---|---|---|
1 | 124.5 | Lamotrigine, 300.0 | Venlafaxine (SNRI), 300.0 | 5 | 15 | |
2 | 166.0 | Lamotrigine, 37.5 | Quetiapine, 300.0 | Sertraline (SSRI), 75.0 | 6 | 5 |
3 | 210.0 | Valproate, 1200.0 | Olanzapine, 5.0 | Citalopram (SSRI), 20.0 | 5 | 21 |
4 | 193.0 | Lamotrigine, 58.3 | Quetiapine, 120.0 | 5 | 18 | |
5 | 207.5 | Quetiapine, 566.7 | Escitalopram (SSRI), 70.0 | 6 | 24 | |
6 | 45.5 | Lamotrigine, 41.7 | Perphenazine, 8.0 | Venlafaxine (SNRI), 225.0 | 6 | 24 |
7 | 156.8 | Lamotrigine, 800.0 | Olanzapine, 2.5 | Bupropion (NDRI), 150.0 | 5 | 20 |
8 | 166.0 | Lamotrigine, 100.0 | Olanzapine, 7.5 | Fluoxetine (SSRI), 20.0 | 6 | 3 |
9 | 332.0 | Lamotrigine, 45.0 | Quetiapine, 180.0 | Mirtazapine (NaSSa), 60.0 | 6 | 35 |
10 | 53.7 | Lamotrigine, 62.5 | Citalopram (SSRI), 12.0; venlafaxine (SNRI), 181.3 | 6 | 29 | |
11 | 166.0 | Olanzapine, 5.0 | Fluoxetine (SSRI), 32.0; paroxetine (SSRI), 10.0e | 6 | 30 | |
12 | Lamotrigine, 316.7 | Quetiapine, 283.3 | 6 | 22 | ||
13 | Lamotrigine, 200.0; valproate, 1500.0 | Olanzapine, 5.0 | Fluoxetine (SSRI), 40.0 | 6 | 15 | |
14 | Lamotrigine, 83.3 | Quetiapine, 204.2 | Mirtazapine (NaSSa), 27.5 | 6 | 10 | |
15 | Lamotrigine, 41.7 | Quetiapine, 75.0 | 6 | 11 | ||
16 | Lamotrigine, 25.0 | Quetiapine, 250.0 | 0 | 44 | ||
17 | Lamotrigine, 466.7 | Quetiapine, 208.3 | 5 | 4 | ||
18 | Lamotrigine, 350.0 | Olanzapine, 30.0 | Fluoxetine (SSRI), 40.0 | 0 | 57 | |
19 | Lamotrigine, 75.0; valproate, 900.0 | Olanzapine, 10.0 | Mirtazapine (NaSSa), 15.0 | 5 | 3 | |
20 | Lamotrigine, 16.7; valproate, 850.0 | Quetiapine, 383.3 | Mirtazapine (NaSSa), 30.0 | 6 | 21 | |
21 | Lamotrigine, 300.0 | Olanzapine, 5.0 | Escitalopram (SSRI), 20.0; mirtazapine (NaSSa), 15.0 | 6 | 43 | |
22 | Lamotrigine, 68.8 | Quetiapine, 300.0 | 5 | 25 | ||
23 | Lamotrigine, 100.0 | Quetiapine, 133.3 | 6 | 9 | ||
24 | Lamotrigine, 300.0 | Quetiapine, 100 | Venlafaxine (SNRI), 120.0; bupropion (NDRI), 150.0 | 6 | 23 | |
25 | Lamotrigine, 10.0; valproate, 1500.0 | Quetiapine, 50.0 | Bupropion (NDRI), 150.0 | 1 | 29 | |
26 | Lamotrigine, 10.0; valproate, 600.0 | Quetiapine, 110.0; olanzapine, 10.0 | 6 | 8 | ||
27 | Lamotrigine, 40.0 | Olanzapine, 20.0 | Fluoxetine (SSRI), 28.0 | 5 | 28 | |
28 | Lamotrigine, 41.7 | Quetiapine, 158.3 | Bupropion (NDRI), 205.0 | 3 | 51 | |
29 | Lamotrigine, 12.5; valproate, 600.0 | Quetiapine, 25.0 | 0 | 20 | ||
30 | Lamotrigine, 30.0; valproate, 450.0 | Olanzapine, 5.0; quetiapine, 450.0 | Venlafaxine (SNRI), 37.5f | 6 | 21 | |
31 | Lamotrigine, 115.0 | Olanzapine, 12.0 | 6 | 19 | ||
32 | Lamotrigine, 120.8; valproate, 1300.0 | Aripiprazole, 15.0g | 6 | 25 | ||
33 | Quetiapine, 545.8 | 6 | 21 |
Efficacy
Response and Remission Rates
Adverse Events
Symptom | ECT (N=36) | Algorithm-Based Pharmacological Treatment (N=30) | Relation to Treatment Procedure |
---|---|---|---|
Psychic adverse events | |||
Concentration difficulties | 3 | Improbable | |
Asthenia, lassitude, or increased fatigability | 1 | 2 | Improbable |
Sleepiness or sedation | 3 | Possible | |
Failing memory | 2 | 2 | Probable for the patients in the ECT group |
Depression | 1 | Improbable | |
Tension or inner unrest | 1 | 1 | Possible for the patient in the pharmacological group, probable for the patient in the ECT group |
Increased duration of sleep | 1 | Possible | |
Reduced duration of sleep | 2 | Possible | |
Increased dream activity | 1 | Possible | |
Emotional indifference | 1 | Possible | |
Neurologic adverse event | |||
Epileptic seizures | 1 | Improbable, patient had a complex partial seizure disorder from childhood that was unknown to the treating clinicians at inclusion in the study | |
Autonomic adverse events | |||
Reduced salivation | 1 | Possible | |
Nausea or vomiting | 1 | Possible | |
Constipation | 1 | Probable | |
Orthostatic dizziness | 2 | Probable | |
Increased tendency to sweat | 3 | 1 | Possible for the patient in the pharmacological group, improbable for the patients in the ECT group |
Other adverse events | |||
Rash | 1 | Probable | |
Weight gain | 1 | Possible | |
Weight loss | 1 | Improbable | |
Diminished sexual desire | 2 | 4 | Possible |
Orgasmic dysfunction | 1 | Possible | |
Headache | 1 | Probable | |
Death (due to an overdose of illicit drugs after discharge from hospital) | 1 | Improbable | |
Medication overdose with possible suicidal ideation | 1 | 2 | Improbable |
Self-strangulation attempt | 1 | Improbable | |
Possible suicide attempt (patient jumped from a cliff) | 1 | Improbable | |
Tooth damage | 1 | Probable | |
Rib fracture | 1 | Improbable; the rib fracture occurred as the result of an accident unrelated to treatment |
Discussion
Footnotes
References
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