Mood Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
Conditions
Keywords
Low Pulse Amplitude Seizure Therapy, Electroconvulsive Therapy, Low Pulse Amplitude Electroconvulsive Therapy, Low Pulse Amplitude ECT, LAP, LAP-ST, ECT, Mood disorders, Psychotic disorders
Brief summary
This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome).
Detailed description
This is hypothesized to increase stimulation focality, thus minimizing cognitive side effects compared to conventional ECT. The study will enroll 22 patients recruited from the Behman Hospital, Cairo, Egypt. Patients referred to ECT service in the Behman Hospital who are clinically indicated to do ECT for major depressive episode of a mood disorder or psychotic episode of a primary psychotic disorder will be approached. Eligible participants who signed informed consent will be included to receive a course of Right Unilateral Ultrabrief LAP-ST.
Interventions
DEVICEMecta spectrum 5000Q device
LAP-ST and Right Unilateral (RUL) electrode placement.
Sponsors
Behman Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. ECT clinically indicated 2. Males or females over 22 to 80 years of age 3. Use of effective method of birth control for women of child-bearing capacity 4. Patient is medically stable 5. Capacity of patient to fully participate in the informed consent process as evaluated by their clinician
Exclusion criteria
1. Current unstable or serious medical condition, or any co-morbid medical condition that substantially increases the risks of ECT 2. History of conditions that may make ECT unsafe such as metal in the head, or a skull defect 3. Female patients who are currently pregnant or plan to be pregnant during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (by successfully inducing therapeutic seizures during LAP-ST course) | From first to last session of LAP-ST course (average approximately 2 weeks) | Measured by: the elicitation of therapeutic seizure in the brain and assessed by using EEG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Memory (cognitive side effects) | From Baseline to end of acute course (average 2 weeks) | Measured by: Mini Mental State Examination |
| Time to reorientation | From Baseline to end of acute course (average 2 weeks) | Measured by: Time to Orientation Test |
| Efficacy | From Baseline to end of acute course (average 2 weeks) | Montgomery-Åsberg Depression Rating Scale (MADRS) for depressive episodes of mood disorders |
Outcome results
None listed