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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 April 2016 |
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Main ID: |
NCT02462551 |
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Date of registration:
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02/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Focal Electrically Administered Seizure Therapy for the Treatment of Depression
FEAST |
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Scientific title:
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Investigating the Effects of Focal Electrically Administered Seizure Therapy (FEAST) for the Treatment of Depression |
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Date of first enrolment:
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September 2013 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02462551 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Ziad Nahas, MD, MSCR |
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Address:
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Telephone:
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00961-1-350000 |
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Email:
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zn17@aub.edu.lb |
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Affiliation:
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Name:
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Ziad Nahas, MD, MSCR |
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Address:
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Telephone:
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00961-1-350000 |
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Email:
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zn07@aub.edu.lb |
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Affiliation:
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Name:
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Ziad Nahas, MD, MSCR |
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Address:
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Telephone:
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Email:
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Affiliation:
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American University of Beirut Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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]
Exclusion Criteria:
- 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]
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Treatment-Resistant Depression
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Intervention(s)
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Device: Focal Electrically Administered Seizure Therapy
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Primary Outcome(s)
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Spatial and temporal distribution and power of induced seizure on EEG recordings
[Time Frame: 15 min before to 5 min after stimulus delivery for the first 3 sessions in a maximum period of two weeks]
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Secondary Outcome(s)
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Change in Depression Scores
[Time Frame: Baseline and 4-6 weeks]
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Time for Reorientation
[Time Frame: 30 minutes]
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Secondary ID(s)
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21024/ PSY.ZN.03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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