Optimizing Electroconvulsive Therapy for Depression

NCT00045916 | Completed Phase 4

• 3 other identifiers: #3891R01MH061609DSIR 83-ATSO
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Depression; Depressive Disorder; Bipolar Disorder

Keywords

Electroconvulsive therapy; Antidepressive Agents

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Memory function

  Measured before and after ECT

Study Arms (6)

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.

Procedure: High dosage electroconvulsive therapy; Drug: Nortriptyline; Drug: Lithium

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.

Procedure: High dosage electroconvulsive therapy; Drug: Venlafaxine; Drug: Lithium

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.

Procedure: High dosage electroconvulsive therapy; Drug: Lithium

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.

Drug: Nortriptyline; Drug: Lithium; Procedure: Low dosage electroconvulsive therapy

Low dosage ECT + venlafaxine

EXPERIMENTAL

Participants will receive venlafaxine and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.

Drug: Venlafaxine; Drug: Lithium; Procedure: Low dosage electroconvulsive therapy

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.

Drug: Lithium; Procedure: Low dosage electroconvulsive therapy

Interventions

High dosage electroconvulsive therapy PROCEDURE

Participants will receive high dosage right unilateral ECT at six times the seizure threshold.

High dosage ECT + nortriptyline; High dosage ECT + placebo; High dosage ECT + venlafaxine

Nortriptyline DRUG

Participants will receive nortriptyline.

High dosage ECT + nortriptyline; Low dosage ECT + nortriptyline

Venlafaxine DRUG

Participants will receive venlafaxine.

High dosage ECT + venlafaxine; Low dosage ECT + venlafaxine

Lithium DRUG

Participants will receive lithium.

High dosage ECT + nortriptyline; High dosage ECT + placebo; High dosage ECT + venlafaxine; Low dosage ECT + nortriptyline; Low dosage ECT + placebo; Low dosage ECT + venlafaxine

Low dosage electroconvulsive therapy PROCEDURE

Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.

Low dosage ECT + nortriptyline; Low dosage ECT + placebo; Low dosage ECT + venlafaxine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Washington University

St Louis, Missouri, 63110, United States

Location

New York State Psychiatric Institute at Columbia University

New York, New York, 10032, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27103, United States

Location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• 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.

  PMID: 11255384 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.

  PMID: 10807482 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.

  PMID: 10807483 BACKGROUND

• 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.

  PMID: 23158959 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder; Bipolar Disorder

Interventions

Nortriptyline; Venlafaxine Hydrochloride; Lithium

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Harold A. Sackeim, PhD

  New York State Psychiatric Institute and Columbia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2002
• First Posted: September 17, 2002
• Study Start: February 1, 2001
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 13, 2013

Record last verified: 2008-10

Locations

US (4)