A randomized, double-blind, placebo-controlled, Phase 2b trial with an open-label extension to determine the safety and efficacy of GH001 in patients with treatment-resistant depression.
This research study is investigating a new medication called GH001 for adults who have treatment-resistant depression. This means their depression hasn't gotten better with standard medications or therapies. The study wants to find out if GH001 can safely reduce symptoms of depression. Some participants will receive GH001, while others will get a placebo (a dummy treatment) to fairly compare its effects. "Double-blind" means neither you nor your study doctor will know which treatment you are receiving until after the study is over. This helps ensure the results are unbiased. Afterwards, all participants will have the chance to continue taking GH001 if they wish. The main goal is to see how much people's depression symptoms change after seven days.
At a glance
What is this study about?
This study is looking for a new way to help people with depression that hasn't improved with typical treatments. This type of depression is called 'treatment-resistant depression' (TRD). When someone has TRD, it can be very difficult to find something that works, and new options are desperately needed.
The medication being tested is called GH001. Researchers want to understand if GH001 is safe to use and if it can help improve symptoms of depression. To do this fairly, some people in the study will receive GH001, and others will get a 'placebo', which looks like GH001 but contains no active medicine. Neither you nor your study doctor will know who is getting which treatment during the main part of the study; this is called 'double-blind' and helps ensure the results are as accurate as possible.
The main part of the study will check how your mood changes after about a week using a common depression rating scale. After this initial stage, everyone who participated will have the chance to continue receiving GH001 if they want to, in what's known as an 'open-label extension'. This extension helps researchers gather more information on the long-term safety and effects of the medication.
Key takeaways
- This study is for adults with depression that hasn't responded to other treatments.
- It tests a new medication called GH001 to see if it's safe and helps improve mood.
- Some people will get the active drug, others a dummy treatment (placebo).
- Participation involves regular clinic visits and assessments.
- You'll have the option to continue with the active treatment after the main study.
- Your safety and wellbeing are a top priority throughout the study.
Who may be eligible?
This study is for adults aged 18 and over who have been diagnosed with depression that hasn't responded well to standard treatments. This includes men and women from all backgrounds.
To be considered, your doctor will need to confirm that your depression meets the criteria for 'treatment-resistant'. There will also be other health checks to make sure you can safely take part in the study and that the results will be clear.
Specific details about other medical conditions, medications you are currently taking, or other factors will be discussed with you by the study doctor to determine if this study is suitable for you.
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 18 years old or older?
- Have you been diagnosed with depression?
- Has your depression not gotten better with standard treatments?
- Are you willing and able to attend regular study visits?
What does participation involve?
If you decide to take part, you will first have a screening visit to check if the study is right for you. If you qualify, you will come for regular visits to the clinic where you will receive the study medication (GH001 or placebo). The medication is given via an inhalation vapour. During these visits, you will have various health checks, such as blood tests, physical examinations, and answer questions about your mood and how you are feeling (using questionnaires like the MADRS). These assessments help the study doctors understand how the treatment is affecting you.
After the main part of the study, which lasts for a short period (we aim to see changes within 7 days), you will have the option to continue with the open-label extension. This means you would then know you are receiving GH001. There will be ongoing follow-up visits to monitor your health and any effects of the treatment. The total duration of your involvement, including the extension, will be explained in detail by the study team.
Potential risks and benefits
Locations (5)
- —UnverifiedPoland
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedIreland
Common questions
What is 'treatment-resistant depression'?
It means your depression hasn't significantly improved after trying usual treatments like antidepressants or therapy.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real medication but doesn't contain any active drug.
Will I know if I'm getting the real drug or the placebo?
During the main part of the study, neither you nor your doctor will know. This helps make the study fair. After the main study, you would know if you choose to continue with the active drug in the extension part.
How is the medication given?
The medication is given as an 'inhalation vapour', meaning you breathe it in.
How long does the main study last?
The main part of the study focuses on changes observed within 7 days. The full duration of your participation, including the optional extension, will be explained.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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