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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH061609 | U.S. NIH Grant/Contract | View source | |
| DSIR 83-ATSO |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ECT.
This study addresses 2 issues in the optimization of ECT in patients with major depression: whether patients treated with ECT should receive concurrent treatment with antidepressant medications, and the relative efficacy and side effects of high dosage right unilateral (RUL) ECT compared to low dosage bilateral (BL) ECT.
This study has 2 phases. In Phase I, patients are randomized to receive nortriptyline, venlafaxine (Effexor), or placebo while they simultaneously receive either high dosage RUL ECT or low dosage BL ECT. Patients have an electrocardiogram (EKG), a chest x-ray, medical and neurological examinations, and blood tests. Memory function is assessed before and after ECT. Whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ECT. ECT is administered 3 times per week to inpatients and twice a week to outpatients. Patients continue ECT until they are asymptomatic or until there is a plateau in improvement over 2 treatments.
Patients who respond to ECT enter Phase II and add lithium to either nortriptyline or venlafaxine within 1-3 days of the last ECT. Clinical and side effect evaluations and blood level determinations are conducted weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks. Following any indication of relapse, patients are monitored more intensively and are re-evaluated within 1 week. The neurocognitive battery is readministered to all patients at 2 and 6 months after the acute ECT course, regardless of ECT clinical outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dosage ECT + nortriptyline | Experimental | Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment. |
|
| High dosage ECT + venlafaxine | Experimental | Participants will receive venlafaxine and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment. |
|
| High dosage ECT + placebo | Placebo Comparator | Participants will receive placebo and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks. |
|
| Low dosage ECT + nortriptyline | Experimental | Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment. |
|
| Low dosage ECT + venlafaxine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dosage electroconvulsive therapy | Procedure | Participants will receive high dosage right unilateral ECT at six times the seizure threshold. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive battery | Measured at baseline and at 2 and 6 months after the acute ECT course | |
| Clinical evaluations, side effect evaluations, and blood level determinations | Measured weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Memory function | Measured before and after ECT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold A. Sackeim, PhD | New York State Psychiatric Institute and Columbia University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States | ||
| New York State Psychiatric Institute at Columbia University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11255384 | Background | Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. doi: 10.1001/jama.285.10.1299. | |
| 10807482 | Background | Sackeim HA, Prudic J, Devanand DP, Nobler MS, Lisanby SH, Peyser S, Fitzsimons L, Moody BJ, Clark J. A prospective, randomized, double-blind comparison of bilateral and right unilateral electroconvulsive therapy at different stimulus intensities. Arch Gen Psychiatry. 2000 May;57(5):425-34. doi: 10.1001/archpsyc.57.5.425. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009661 | Nortriptyline |
| D000069470 | Venlafaxine Hydrochloride |
| D008094 | Lithium |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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Participants will receive venlafaxine and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment. |
|
| Low dosage ECT + placebo | Experimental | Participants will receive placebo and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks. |
|
| Nortriptyline | Drug | Participants will receive nortriptyline. |
|
| Venlafaxine | Drug | Participants will receive venlafaxine. |
|
| Lithium | Drug | Participants will receive lithium. |
|
| Low dosage electroconvulsive therapy | Procedure | Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold. |
|
| New York |
| New York |
| 10032 |
| United States |
| Wake Forest University | Winston-Salem | North Carolina | 27103 | United States |
| Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
| 10807483 | Background | McCall WV, Reboussin DM, Weiner RD, Sackeim HA. Titrated moderately suprathreshold vs fixed high-dose right unilateral electroconvulsive therapy: acute antidepressant and cognitive effects. Arch Gen Psychiatry. 2000 May;57(5):438-44. doi: 10.1001/archpsyc.57.5.438. |
| 23158959 | Derived | McCall WV, Reboussin D, Prudic J, Haskett RF, Isenberg K, Olfson M, Rosenquist PB, Sackeim HA. Poor health-related quality of life prior to ECT in depressed patients normalizes with sustained remission after ECT. J Affect Disord. 2013 May;147(1-3):107-11. doi: 10.1016/j.jad.2012.10.018. Epub 2012 Nov 15. |
| D000068105 |
| Bipolar and Related Disorders |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D008055 | Lipids |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |