Optimizing Electroconvulsive Therapy for Depression

Depression Clinical Trial

Official title:

Optimization of Electroconvulsive Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045916
• Other study ID #: #3891
• Secondary ID: R01MH061609DSIR
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2002
• Last updated: August 9, 2013
• Start date: February 2001
• Est. completion date: December 2006

Study information

• Verified date: October 2008
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 Whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ECT.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major depressive episode (unipolar or bipolar)

• 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:

• Schizophrenia, schizoaffective disorder, or other psychosis

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Disease

Intervention

Procedure:
• High dosage electroconvulsive therapy
Participants will receive high dosage right unilateral ECT at six times the seizure threshold.

Drug:
• Nortriptyline
Participants will receive nortriptyline.
• Venlafaxine
Participants will receive venlafaxine.
• Lithium
Participants will receive lithium.

Procedure:
• Low dosage electroconvulsive therapy
Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute at Columbia University	New York	New York
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania
United States	Washington University	St. Louis	Missouri
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive battery		Measured at baseline and at 2 and 6 months after the acute ECT course	Yes
Primary	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	Yes
Secondary	Memory function		Measured before and after ECT	Yes