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Tests treatment safety and results for Posttraumatic Stress Disorder
Official title Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD
ClinicalTrials.gov ID: NCT05133804
What this study is testing
What is Methylphenidate?
Methylphenidate is an investigational medicine, given as an once-daily, being studied as a potential treatment for posttraumatic stress disorder.
Also referred to as Ritalin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Up-to-date, no studies have examined the attentional, sensory and emotional processing (difficulties) among patients diagnosed with Posttraumatic Stress Disorder (PTSD). In addition, the efficiency of drug treatments that focus on the noradrenergic and dopaminergic, and thus influence attention processing and PTSD symptoms through these pathways, have only briefly been investigated.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 60. Healthy volunteers may be eligible.
You may be able to join if
- diagnosed with PTSD according to DSM-IV or DSM-5 criteria
- current treatment at the outpatient facilities of Lev HaSharon Netanya Adult Clin
- age between 20 and 60 years
- PTSD diagnosis at least one month prior to study inclusion
- no present-day re-exposure to the traumatic event
You likely can't join if
- comorbid major psychiatric disorder, e.g. psychotic disorder, unipolar or bipolar disorder, borderline personality disorder, or active suicidal...
- ADHD diagnosis,
- significant or severe systematic disease that limits normal activity, e.g. autoimmune disease, AIDS or renal failure,
- cardiovascular disease, e.g. hypertension, atrioventricular (AV) block, bradycardia, or conduction disorder,
- severe disease that is a threat to life, e.g. acute myocardial infarction, respiratory failure, or cancer,
- nervous system impairment, e.g. multiple sclerosis, Alzheimer's disease, Parkinson's disease, epilepsy, or stroke,
See the full eligibility criteria
- diagnosed with PTSD according to DSM-IV or DSM-5 criteria
- current treatment at the outpatient facilities of Lev HaSharon Netanya Adult Clin
- age between 20 and 60 years
- PTSD diagnosis at least one month prior to study inclusion
- no present-day re-exposure to the traumatic event
- any psychotropic drug therapy that is being administered must be at a fixed dose for at least one month prior to the study conductance
- comorbid major psychiatric disorder, e.g. psychotic disorder, unipolar or bipolar disorder, borderline personality disorder, or active suicidal ideation,
- ADHD diagnosis,
- significant or severe systematic disease that limits normal activity, e.g. autoimmune disease, AIDS or renal failure,
- cardiovascular disease, e.g. hypertension, atrioventricular (AV) block, bradycardia, or conduction disorder,
- severe disease that is a threat to life, e.g. acute myocardial infarction, respiratory failure, or cancer,
- nervous system impairment, e.g. multiple sclerosis, Alzheimer's disease, Parkinson's disease, epilepsy, or stroke,
- previous or current severe traumatic brain injury,
- glaucoma,
- impaired hearing,
- pregnancy or breastfeeding during study inclusion,
- active substance dependency including regular use of medical cannabis,
- use of steroid medication in the two months prior to study conductance,
- use of medication that may affect the function of the central nervous system,
- failure to complete all research steps
The study team makes the final eligibility decision.
Where it's taking place
- Afula, Israel
- Haifa, Israel
- Netanya, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Afula, Israel; Haifa, Israel; Netanya, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.