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A double-blind, randomized, controlled trial on the effect of PEX010 for prolonged grief disorder
EU CTIS ID: 2024-518218-24-00
What this study is testing
The primary objective of this trial is to determine whether scores on the revised prolonged grief disorder scale will be reduced significantly after the PEX010 dosing session.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject has given their written consent to participate in the trial.
- PG13-R score 30 or higher
- Good health as determined by medical history, ECG, and clinical assessment of lab tests. Lab tests will include electrolytes (sodium, potassium, chloride, magnesium, calcium, phosphate), GFR, creatinine, glucose, complete blood count, hemoglobin, MCV, white blood cells, platelets, TSH, liver panel including total bilirubin, ALP, AST, ALT, GGT. The final decision will be according to the judgment of a study physician.
You likely can't join if
- Any clinically significant medical condition as determined by medical history and lab tests, including CNS, cardiovascular disorders including uncontrolled hypertension (greater than 165/95), respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders, as assessed by the Principal Investigator (PI) or designee, after appropriate consultation if needed.
- Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine during the past year (defined in DSM-5 terms as Substance Use Disorder, Moderate or Severe;), as assessed by PI or designee.
- History of psychotic experiences or suicidality, or family history (first degree relatives) of psychosis.
- History of bipolar disorder or family history (first degree relatives) of bipolar disorder.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.