Comparing the Effects of Four Types of Electroconvulsive Therapy on Mood and Thinking in People With Depression

NCT00487500 | Completed Phase 4 DMC

• 2 other identifiers: #34825R01MH035636
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare four types of electroconvulsive therapy to determine if they differ in their effects on mood, thinking, brain activity, and biochemistry in people with major depressive disorder.

Conditions

Depression

Keywords

Major Depressive Disorder; Electroconvulsive Therapy

Outcome Measures

Primary Outcomes (2)

• Short-term antidepressant efficacy

  Primary outcome reflected change in HRSD depression symptom scores.

  Measured immediately post-treatment and 2, 4, and 6 months post-treatment

• Specific acute, short-term, and long-term objective and subjective cognitive outcome measures (e.g., autobiographical amnesia, global self-rating of amnesia)

  Specific neuropsychological measures were preselected as primary in safety analyses

  Measured immediately post-treatment and 2, 4, and 6 months post-treatment

Secondary Outcomes (3)

• Antidepressant efficacy

  Measured immediately post-treatment and 2, 4, and 6 months post-treatment

• Assessments of functional outcomes

  Measured immediately post-treatment and 2, 4, and 6 months post-treatment

• Memory, non-memory, and executive functions (acute, short-term, and long-term measures)

  Measured immediately post-treatment and 2, 4, and 6 months post-treatment

Study Arms (4)

Ultrabrief, Right Unilateral ECT

EXPERIMENTAL

Right unilateral ECT administered with an ultrabrief pulse width (0.3 ms), at a dose 6 times the initial seizure threshold

Device: Electroconvulsive Therapy (ECT)

Ultrabrief, Bilateral ECT (2.5 X ST)

EXPERIMENTAL

Bilateral (frontotemporal) ECT with an ultrabrief pulse width with dosage 2.5 times the initial seizure threshold

Device: Electroconvulsive Therapy (ECT)

Brief Pulse, Right Unilateral ECT

ACTIVE COMPARATOR

Right unilateral ECT, with a standard brief pulse (1.5 ms), with dosage 6 times the initial seizure threshold

Device: Electroconvulsive Therapy (ECT)

Brief Pulse, Bilateral ECT

ACTIVE COMPARATOR

Bilateral (frontotemporal) ECT with a standard brief pulse (1.5 ms), with dosage 2.5 times the initial seizure threshold

Device: Electroconvulsive Therapy (ECT)

Interventions

Electroconvulsive Therapy (ECT) DEVICE

Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure

Also known as: shock therapy

Brief Pulse, Bilateral ECT; Brief Pulse, Right Unilateral ECT; Ultrabrief, Bilateral ECT (2.5 X ST); Ultrabrief, Right Unilateral ECT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of major depressive disorder
• Pretreatment score of at least 18 on the Hamilton Rating Scale for Depression
• Able to tolerate psychotropic washout and no psychotropic medication, other than lorazepam (up to 3 mg/d PRN), during the study
• Recommended to receive ECT

You may not qualify if:

• History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder
• Secondary diagnosis of a delirium, dementia, or amnestic disorder, or epilepsy
• Pregnant
• History of neurological illness other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia)
• History of alcohol or substance abuse within the year prior to study entry
• History of ECT within the 6 months prior to study entry

Sponsors & Collaborators

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

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (2)

• Sackeim, H. A.: The convulsant and anticonvulsant properties of electroconvulsive therapy: towards a focal form of brain stimulation. Clinical Neuroscience Review, 2004, 4:39-57.

  RESULT

• Sackeim HA, Prudic J, Nobler MS, Fitzsimons L, Lisanby SH, Payne N, Berman RM, Brakemeier EL, Perera T, Devanand DP. Effects of pulse width and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. Brain Stimul. 2008 Apr;1(2):71-83. doi: 10.1016/j.brs.2008.03.001.

  PMID: 19756236 RESULT

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Harold A. Sackeim, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: December 1, 1998
• Primary Completion: December 1, 2002
• Study Completion: May 1, 2005
• Last Updated: August 18, 2014

Record last verified: 2007-06

Locations

US (1)