Informed Consent Form for Phase 2 Clinical Trial:
Emotional Pairing Agent
This document provides information about a research study (clinical trial) investigating an Emotional Pairing Agent (hereafter referred to as Symphonia). We are inviting couples or established partners in committed relationships to participate in this Phase 2 trial to assess the efficacy of Symphonia in promoting emotional alignment.
What is Emotional Pairing?
Emotional pairing proposes the possibility of simultaneously coordinating emotional states by promoting neurotransmitter synchrony between one or more partners. The theory suggests that Symphonia, by dynamically regulating the patients’ mirror neurons, will optimise empathy pathways. This innovative method of neuromodulation aims to help partners in established couples, triads, or other committed partnerships find deeper emotional harmony, improve communication, and tangibly redistribute mental load.
Be a Part of Scientific Discovery
Building on the encouraging results of Phase 1, Symphonia’s Phase 2 trial represents a significant step forward in the field of neuroscience. By participating, you and your partner(s) will be contributing to ground-breaking research that could have a profound impact on our understanding of emotional communication within relationships, especially when it comes to the shared management of our emotions.
Chronic mental illness in one partner can often take a toll on the entire relationship. Difficulties with emotional strain, isolation, and feelings of shame have become increasingly common challenges in modern relationships. This Phase 2 trial is exploring the potential of Symphonia to promote emotional alignment for sustained empathy when such imbalances occur, which could lead to improved responses and coping mechanisms.
Consequently, Symphonia has the potential to revolutionise our approach to relationship dynamics as a species.
Important Information
· The trial will involve established partners in committed relationships.
· You will participate with your partner(s) throughout the study.
· Symphonia is an investigational drug, and its long-term effects are unknown.
· Participation in this trial is voluntary.
· You will be compensated for your time and participation in this research study. (Details below)
Inclusion Criteria (All Partners Must Meet All Criteria):
· You are between 18 and 55 years old.
· You are in good general health as determined by a medical evaluation. (Individuals with well-managed mental health conditions, as determined by the research team and documented by a healthcare professional, can be considered on a case-by-case basis)
· You are in a committed relationship (couple, established triad, or other committed partnership) for at least one year (cohabitation or equivalent).
· You are all willing and able to comply with all study procedures and follow-up visits.
· You are willing to abstain from certain medications and activities during the study. (Details will be provided)
· You are all able to understand and sign this informed consent form.
Exclusion Criteria (Any Partner Meeting Any Criteria Excludes All Partners):
· You are pregnant or breastfeeding.
· You are taking certain medications that may interact with Symphonia.
· You have a history of substance abuse or dependence.
· You have an untreated medical or psychiatric illness.
· You are currently undergoing marital or relationship therapy.
What will Happen During the Study?
· The study will consist of screening procedures, multiple clinic visits together and individually, and follow-up assessments.
· During screening, you and your partner(s) will undergo separate medical evaluations, blood tests, and psychological assessments to determine your eligibility.
· If you qualify, you will be randomly assigned (double-blind) to receive either Symphonia or a placebo (inactive substance) for all partners.
· You will receive the study drug or placebo at designated doses throughout the trial.
· You will be closely monitored for any side effects during the study.
· Blood samples and other assessments will be conducted to track the drug's effects on your bodies.
· You will participate in individual and group therapy sessions throughout the study to assess communication and emotional states.
What are the Risks and Benefits of Participating?
Risks:
· Symphonia is an investigational drug, and its potential side effects are unknown.
· You or your partner(s) may experience side effects from the drug or placebo.
· The study procedures themselves may involve some discomfort or inconvenience.
· The possibility exists that Symphonia could exacerbate existing emotional distress in one or more partners.
· There is no guarantee of benefit from participating in this trial.
· The psychoactive nature of the drug could potentially affect your relationship dynamics in unforeseen ways.
Benefits:
· You will be contributing to scientific research on emotional pairing.
· You and your partner(s) will receive all study-related medical care at no cost.
· You will be compensated for your time and participation.
· The therapy sessions offered throughout the study may benefit your relationship regardless of whether you receive Symphonia or a placebo.
Your Rights
· Your participation in this trial is voluntary.
· You and your partner(s) can all withdraw from the trial at any time, for any reason, without penalty.
· You all have the right to ask questions about the study at any time.
· You all have the right to access your individual medical information collected during the study.
Compensation
· The specific amount of compensation will vary depending on the length of your visits, the number of procedures involved, and the total duration of your participation.
· We anticipate that participants will receive 600 – 3600 CREDITS per visit.
· You will receive a detailed breakdown of the compensation schedule after you complete the screening process.
Be a Part of Something Bigger
Beyond the Phase 2 clinical trial, Symphonia has the potential to pave the way for a more empathetic human experience. If you share our vision of a deeply bonded, more connected world, we encourage you to reach out and join us today.
If you would like to learn more about Symphonia, please review this informed consent form together. We encourage you to discuss your questions and concerns with the research team or your personal physicians.