A study to evaluate the safety of NTX-1955 in patients with generalised anxiety disorder
This study is looking into a new medication called NTX-1955 for adults aged 18-55 who have generalised anxiety disorder (GAD). The main goal is to check how safe it is and if people can tolerate it well. Participants will either receive NTX-1955 or a 'dummy' pill (called a placebo) for two weeks. This drug has been tested in healthy people and shown to be well-tolerated. Now, researchers want to see its effects in a small group of people who actually have GAD. You'll have several visits for check-ups and tests, and any side effects will be closely monitored.
At a glance
What is this study about?
This study is investigating a new medication called NTX-1955, which is being developed to help people with generalised anxiety disorder, often shortened to GAD. GAD is a condition where people experience frequent and excessive worry about everyday things, which can be hard to control and can affect their daily life.
The main purpose of this study is to discover if NTX-1955 is safe for people with GAD. It's called a 'Phase I' study, which means it's one of the first times this drug is being tested in people who have the condition. Researchers also want to see how well people tolerate the drug – meaning if it causes uncomfortable side effects. The drug has already been given to healthy volunteers, and they generally coped well with it.
During the study, some participants will receive the actual drug, NTX-1955, while others will receive a 'placebo.' A placebo looks exactly like the study drug but doesn't contain any active ingredients. This helps researchers compare the effects of the actual drug against what happens when someone doesn't take the drug, making the results clearer and more reliable. This helps us understand if any changes or improvements are genuinely due to the new medication.
Key takeaways
- This study is testing a new drug for generalised anxiety disorder (GAD).
- It aims to check the safety and how well people tolerate the drug, NTX-1955.
- You might receive the new drug or a dummy pill (placebo).
- The study involves taking a capsule daily for two weeks and attending several clinic visits.
- Potential side effects include confusion, sleepiness, or changes in liver tests.
- You can stop participating at any point.
Who may be eligible?
This study is looking for adults aged between 18 and 55 years old who have been diagnosed with generalised anxiety disorder (GAD). You'll need to have had GAD symptoms for at least six months.
There are also some other important health checks. For example, your weight needs to be within a certain range. If you are receiving talking therapy (like counselling), it's generally fine, as long as you've been stable on it for a while and plan to continue it. If you're not in therapy, you'd need to agree not to start until after the study period.
However, some things would mean you couldn't take part. This includes having other serious mental health conditions like a history of psychosis or bipolar disorder, or if you've recently had thoughts of harming yourself. Also, if you've had issues with alcohol or drug use in the last year, or are taking certain other medications that could react with the study drug, you wouldn't be able to join. Women who are pregnant or breastfeeding cannot participate, and all participants capable of becoming pregnant or fathering a child must agree to use effective contraception.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 55 years old?
- Have you been diagnosed with Generalised Anxiety Disorder (GAD)?
- Are you able to attend clinic visits for check-ups and tests?
- Are you willing and able to use contraception if required?
- Do you have a Body Mass Index (BMI) between 18 and 35, and weigh at least 50kg?
- Are you currently not pregnant or breastfeeding?
What does participation involve?
If you decide to take part, you'll first have a screening visit to check if the study is right for you. This will involve various tests and discussions about your health and medical history. If you're suitable, you would then take a capsule of either NTX-1955 (at one of two possible dose levels) or a placebo once a day for two weeks.
Throughout the study, you'll need to attend clinic visits. After your initial screening, there will be five more visits for check-ups and medical tests. These tests might include blood samples, checking your heart's electrical activity (ECG), and looking at brain activity (qEEG). The study is expected to run from October 2025 to August 2026, though your individual participation period will be much shorter.
Potential risks and benefits
Locations (1)
- -Approximate-, England
Common questions
What is generalised anxiety disorder (GAD)?
GAD is a condition where people experience excessive and often uncontrollable worry about everyday situations for a long time, making it hard to go about their daily life.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the study drug but doesn't actually contain any medication. It helps researchers compare the effects of the real drug.
How long will I be involved in the study?
Your main involvement will be taking the study drug or placebo for two weeks, along with a screening visit and five follow-up clinic visits.
Will I know if I'm getting the real drug or the placebo?
No, neither you nor the study team will know who is receiving the active drug and who is receiving the placebo. This is called 'double-blind' and helps ensure unbiased results.
Can I stop participating if I want to?
Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Rebecca Tregent
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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