Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
340 participants
INTERVENTIONAL
2001-02-28
2006-12-31
Brief Summary
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Detailed Description
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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 Whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ECT.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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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High dosage ECT + nortriptyline
Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
High dosage electroconvulsive therapy
Participants will receive high dosage right unilateral ECT at six times the seizure threshold.
Nortriptyline
Participants will receive nortriptyline.
Lithium
Participants will receive lithium.
High dosage ECT + venlafaxine
Participants will receive venlafaxine and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
High dosage electroconvulsive therapy
Participants will receive high dosage right unilateral ECT at six times the seizure threshold.
Venlafaxine
Participants will receive venlafaxine.
Lithium
Participants will receive lithium.
High dosage ECT + placebo
Participants will receive placebo and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks.
High dosage electroconvulsive therapy
Participants will receive high dosage right unilateral ECT at six times the seizure threshold.
Lithium
Participants will receive lithium.
Low dosage ECT + nortriptyline
Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
Nortriptyline
Participants will receive nortriptyline.
Lithium
Participants will receive lithium.
Low dosage electroconvulsive therapy
Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.
Low dosage ECT + venlafaxine
Participants will receive venlafaxine and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
Venlafaxine
Participants will receive venlafaxine.
Lithium
Participants will receive lithium.
Low dosage electroconvulsive therapy
Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.
Low dosage ECT + placebo
Participants will receive placebo and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks.
Lithium
Participants will receive lithium.
Low dosage electroconvulsive therapy
Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.
Interventions
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High dosage electroconvulsive therapy
Participants will receive high dosage right unilateral ECT at six times the seizure threshold.
Nortriptyline
Participants will receive nortriptyline.
Venlafaxine
Participants will receive venlafaxine.
Lithium
Participants will receive lithium.
Low dosage electroconvulsive therapy
Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.
Eligibility Criteria
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Inclusion Criteria
* Pre-ECT score of 20 or higher on Hamilton Rating Scale for Depression
* Able to withdraw psychotropic drugs (up to 3 mg/day lorazepam allowed)
* ECT indicated
Exclusion Criteria
* Amnestic disorder, dementia, or delirium
* Pregnancy
* Epilepsy
* Current alcohol or substance abuse or dependence
* CNS disease or brain injury not associated with psychotropic drug exposure
* ECT in the past 6 months
* Medical contraindication for treatment with either nortriptyline or venlafaxine, including allergy to amitriptyline, nortriptyline, or venlafaxine; narrow angle glaucoma; sinus node disease; bundle branch disease; myocardial infarction; coronary artery bypass or angioplasty; or angina
* Type I antiarrhythmic medication
* Supine blood pressure \>= 170 mmHg systolic or \>= 105 mmHg diastolic at 3 readings over 2 days
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Principal Investigators
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Harold A. Sackeim, PhD
Role: STUDY_CHAIR
New York State Psychiatric Institute and Columbia University
Locations
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Washington University
St Louis, Missouri, United States
New York State Psychiatric Institute at Columbia University
New York, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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DSIR 83-ATSO
Identifier Type: -
Identifier Source: secondary_id
#3891
Identifier Type: -
Identifier Source: org_study_id