Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

Mood Disorders Clinical Trial

Official title:

Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928159
• Other study ID #: 001
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2016
• Last updated: October 6, 2016
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2016
• Source: Behman Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Mood Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders
• Seizures

Intervention

Device:
• Mecta spectrum 5000Q device
LAP-ST and Right Unilateral (RUL) electrode placement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Behman Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (by successfully inducing therapeutic seizures during LAP-ST course)	Measured by: the elicitation of therapeutic seizure in the brain and assessed by using EEG	From first to last session of LAP-ST course (average approximately 2 weeks)	No
Secondary	Memory (cognitive side effects)	Measured by: Mini Mental State Examination	From Baseline to end of acute course (average 2 weeks)	No
Secondary	Time to reorientation	Measured by: Time to Orientation Test	From Baseline to end of acute course (average 2 weeks)	No
Secondary	Efficacy	Montgomery-Åsberg Depression Rating Scale (MADRS) for depressive episodes of mood disorders	From Baseline to end of acute course (average 2 weeks)	No
Secondary	Efficacy	Brief Psychiatric Rating Scale (BPRS) for psychotic disorders	From Baseline to end of acute course (average 2 weeks)