Depressive Disorder
Conditions
Brief summary
The goal of this interventional study is to learn if accelerated Intermittent Theta Burst Stimulation can improve symptoms of 30 participants with Unipolar depression in higher manner than symptoms of 30 participants with bipolar depression
Detailed description
We will apply stimulatory TMS protocol for participants with Unipolar depression and participants with bipolar depression using MagVenture MagPro R30 stimulator with the Cool-B65 coil
Interventions
Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil
DEVICETMS
Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age:18\_65 years * Sex:male and female * Patients with Unipolar depression and bipolar depression diagnosis confirmed by SCID according to DSM5 * No pharmacological change in the last 4 weeks before the beginning of the stimulantion cycle * Pharmacological resistance
Exclusion criteria
* Patients complaining of psychosis.Substance Use Disorder.current suicidal ideation.major medical and neurological disorder * Patients complaining of epilepsy * pregnancy and breastfeeding * peacemaker spinal or bladder stimulator * History of skull surgery and trauma * presence of metallic foreign body
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of severity of manic symptoms before and after treatment | One year for completion of the study | We will use Young Mania Rating Scale.\_Young Mania Rating Scale:assess severity of manic symptoms, clinician rated,\<=12(remission)13\_19(minimal symptoms)20\_25(mild mania)26\_37(moderate mania)38\_60 severe mania |
| Comparison of the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis. | One year for completion of the study | We will use Clinical Global Impression Severity Scale.\_Clinical Global Impression Severity Scale:rate the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis,1 normal not at all ill,2 borderline mentally ill,3 mildly ill,4 moderately ill,5 markedly ill,6 severely ill,7 extremely ill |
| Comparison of severity and impact of insomnia before and after treatment | One year for completion of the study | We will use Insomnia Severity Index scale.\_Insomnia Severity Index:assess the nature, severity and impact of insomnia,0\_7(absence insomnia) 8\_14(subthreshold insomnia)15\_21(moderate insomnia)22\_28(severe insomnia) |
| Comparison of depressive symptoms before and after treatment | One year for completion of the study | We will use Hamilton Depression Rating Scale.\_Hamilton Depression Rating Scale:assess the severity of depressive symptoms, clinician rated,0\_7(normal range)8\_16(mild severity)17\_23(moderate severity)\>23(severe depression) |
Countries
Egypt
Contacts
Primary ContactShaimaa E. Mohamed
Backup ContactWarda F. Aboelez
Outcome results
None listed