Focal Electrically Administered Seizure Therapy for the Treatment of Depression

NCT02462551 | Unknown

• 1 other identifier: 21024/ PSY.ZN.03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and any possible side effects of focal electrically administered seizure therapy (FEAST) as a treatment intervention for patients with recurrent and treatment resistant depression.

Conditions

Treatment-Resistant Depression

Keywords

Depression; Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Spatial and temporal distribution and power of induced seizure on EEG recordings

  EEG recordings will be analyzed to assess the dynamics and characteristics of induced seizure activity; including spatial and temporal distribution, power, and current density in different cortical areas

  15 min before to 5 min after stimulus delivery for the first 3 sessions in a maximum period of two weeks

Secondary Outcomes (2)

• Change in Depression Scores

  Baseline and 4-6 weeks

• Time for Reorientation

  30 minutes

Study Arms (1)

FEAST

EXPERIMENTAL

Patients with treatment-resistant depression will undergo 3 sessions of focal electrically administered seizure therapy for two to six weeks. The complete parameter range of the stimulus delivered (Freq: 20-120 Hz; PW: 0.2-2 ms; Duration: 0.1 to 8 s; Current: 0.5-0.8A; charge: 1-576 mC) is determined by an initial titration session and the PI (as an expert in neuromodulation treatments).

Device: Focal Electrically Administered Seizure Therapy

Interventions

Focal Electrically Administered Seizure Therapy DEVICE

A focal administration of the right unilateral configuration of electro-convulsive therapy for the treatment of recurrent and treatment-resistant depression.

Also known as: FEAST

FEAST

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 90 years (inclusive)
• Diagnosis of major depressive disorder (unipolar or bipolar) \[SCID to derive RDC; DSM-IV\]
• Pretreatment HRSD score ≥ 18 \[Hamilton Rating Scale for Depression (24-item)\]
• ECT indicated \[Physician evaluation\]
• Willing and capable of providing informed consent \[Physician evaluation\]

You may not qualify if:

• History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder \[SADS to derive RDC; rapid cycling defined as ≥ four episodes in past year\]
• History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) \[Physician evaluation; medical history\]
• Alcohol or substance abuse or dependence in the past year (RDC) \[Physician evaluation\]
• Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy \[Physician evaluation\]
• Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. \[Physician evaluation\]
• Unable to tolerate psychotropic washout and no psychotropic medication during the ECT trial, other than lorazepam (up to 3 mg/d PRN) \[Treatment history and physician evaluation\]
• ECT in the past six months \[Physician evaluation; medical history\]
• Has a cardiovascular and/or pulmonary condition \[Physician evaluation\]

Sponsors & Collaborators

• Ziad Nahas: lead
• Columbia University: collaborator
• MECTA corporation: collaborator
• Medical University of South Carolina: collaborator

Study Sites (1)

American University of Beirut Medical Center

Beirut, Beyrouth, Lebanon

RECRUITING

Related Publications (9)

• Spellman T, Peterchev AV, Lisanby SH. Focal electrically administered seizure therapy: a novel form of ECT illustrates the roles of current directionality, polarity, and electrode configuration in seizure induction. Neuropsychopharmacology. 2009 Jul;34(8):2002-10. doi: 10.1038/npp.2009.12. Epub 2009 Feb 18.

  PMID: 19225453 BACKGROUND

• Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA. The effects of electroconvulsive therapy on memory of autobiographical and public events. Arch Gen Psychiatry. 2000 Jun;57(6):581-90. doi: 10.1001/archpsyc.57.6.581.

  PMID: 10839336 BACKGROUND

• Sackeim HA, Luber B, Moeller JR, Prudic J, Devanand DP, Nobler MS. Electrophysiological correlates of the adverse cognitive effects of electroconvulsive therapy. J ECT. 2000 Jun;16(2):110-20. doi: 10.1097/00124509-200006000-00003.

  PMID: 10868321 BACKGROUND

• George MS, Nahas Z, Li X, Kozel FA, Anderson B, Yamanaka K, Chae JH, Foust MJ. Novel treatments of mood disorders based on brain circuitry (ECT, MST, TMS, VNS, DBS). Semin Clin Neuropsychiatry. 2002 Oct;7(4):293-304. doi: 10.1053/scnp.2002.35229.

  PMID: 12382211 BACKGROUND

• Nahas Z, Short B, Burns C, Archer M, Schmidt M, Prudic J, Nobler MS, Devanand DP, Fitzsimons L, Lisanby SH, Payne N, Perera T, George MS, Sackeim HA. A feasibility study of a new method for electrically producing seizures in man: focal electrically administered seizure therapy [FEAST]. Brain Stimul. 2013 May;6(3):403-8. doi: 10.1016/j.brs.2013.03.004. Epub 2013 Mar 16.

  PMID: 23518262 BACKGROUND

• Chahine G, Short B, Spicer K, Schmidt M, Burns C, Atoui M, George MS, Sackeim HA, Nahas Z. Regional cerebral blood flow changes associated with focal electrically administered seizure therapy (FEAST). Brain Stimul. 2014 May-Jun;7(3):483-5. doi: 10.1016/j.brs.2014.02.011. Epub 2014 Feb 22.

  PMID: 24795198 BACKGROUND

• Nobler MS, Luber B, Moeller JR, Katzman GP, Prudic J, Devanand DP, Dichter GS, Sackeim HA. Quantitative EEG during seizures induced by electroconvulsive therapy: relations to treatment modality and clinical features. I. Global analyses. J ECT. 2000 Sep;16(3):211-28. doi: 10.1097/00124509-200009000-00002.

  PMID: 11005043 BACKGROUND

• Luber B, Nobler MS, Moeller JR, Katzman GP, Prudic J, Devanand DP, Dichter GS, Sackeim HA. Quantitative EEG during seizures induced by electroconvulsive therapy: relations to treatment modality and clinical features. II. Topographic analyses. J ECT. 2000 Sep;16(3):229-43. doi: 10.1097/00124509-200009000-00003.

  PMID: 11005044 BACKGROUND

• Kayser S, Bewernick BH, Grubert C, Hadrysiewicz BL, Axmacher N, Schlaepfer TE. Antidepressant effects, of magnetic seizure therapy and electroconvulsive therapy, in treatment-resistant depression. J Psychiatr Res. 2011 May;45(5):569-76. doi: 10.1016/j.jpsychires.2010.09.008. Epub 2010 Oct 16.

  PMID: 20951997 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Ziad Nahas, MD, MSCR

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziad Nahas, MD, MSCR

CONTACT

00961-1-350000; zn17@aub.edu.lb

Mark Doumit, BA,MA

CONTACT

00961-1-350000; md55@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chair of the Department of Psychiatry

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: September 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

LE (1)