Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

AMIND - AMIloride for the treatment of Nephrogenic Diabetes insipidus for patients with bipolar disorder treated with lithium: a randomized controlled trial

This research study is for people who have bipolar disorder and have been taking the medicine lithium for at least five years. Sometimes, long-term lithium use can affect the kidneys, leading to a condition called nephrogenic diabetes insipidus. This condition makes you feel very thirsty and need to pass urine much more often, even at night. The study aims to find out if a different medicine, called amiloride, can help improve these symptoms. Participants will either receive amiloride or a dummy pill (placebo). We will measure how much your urine concentration changes and check on your thirst levels and quality of life over two months, and then for up to a year. This is a Phase II study, meaning we are exploring if the treatment works and is safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

148

Start

09 Aug 2024

Patients treated with lithium carbonate for a bipolar disorder treated for at least 5 years and with a urine concentration defect.

What is this study about?

This study is called AMIND and it's designed for people who have bipolar disorder and have been treated with lithium for at least five years. Lithium is a common and effective medicine for bipolar disorder, but sometimes, after many years of use, it can affect how your kidneys work. This can lead to a condition called nephrogenic diabetes insipidus.

If you have nephrogenic diabetes insipidus, your kidneys don't concentrate urine properly. This means you might feel extremely thirsty all the time, drink a lot of fluids, and then have to go to the toilet very frequently, even during the night. These symptoms can be quite disruptive to daily life. This study wants to see if a medicine called amiloride can help your kidneys work better to concentrate your urine, which would hopefully reduce your thirst and the need to urinate so often.

We will carefully compare amiloride with a dummy pill (placebo) to understand if it truly makes a difference. We'll be looking at various aspects of your health over 12 months, including your kidney function, how well you sleep, and your general well-being, to get a full picture of how amiloride might help. It's important to understand that this is a research study to explore if amiloride is an effective treatment for this specific problem.

Key takeaways

Study for people with bipolar disorder on long-term lithium.
Aims to improve thirst and frequent urination caused by lithium.
Tests a medicine called amiloride against a dummy pill.
Involves health checks over 12 months.
Could help reduce disruptive symptoms of kidney issues.

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women can take part.

You would need to have bipolar disorder and have been taking lithium carbonate regularly for your condition for at least five years. More importantly, you would also need to show signs that your kidneys are having trouble concentrating your urine, which is a key part of nephrogenic diabetes insipidus. This would be checked by medical tests.

There might be other reasons why you wouldn't be able to join, such as other health conditions or medicines you are taking, but the study team would discuss all of these with you in detail.

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 at least 18 years old?
Do you have bipolar disorder?
Have you been taking lithium carbonate for at least 5 years?
Do you experience significant thirst and frequent urination?
Has a doctor told you that your kidneys are having trouble concentrating your urine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for a total of 12 months. For the first two months, you will take either the study medicine (amiloride) or a dummy pill (placebo) every day. You won't know which one you are taking.

Throughout the study, you will have several clinic visits. These visits will involve blood tests, urine tests to check your kidney function, and answering questionnaires about your thirst, how often you go to the toilet during the night, your sleep, mood, and general quality of life. The main check will be at 2 months, but we will also follow up with you at 6 months and 12 months to see how you are doing over a longer period. We will also monitor for any side effects.

Potential risks and benefits

Taking part in this study could potentially offer a benefit if amiloride helps improve your symptoms of excessive thirst and frequent urination. We will also carefully monitor your health and kidney function throughout the study. However, there's no guarantee that you will personally benefit from taking part, as you might receive the dummy pill and not the active medicine. Like all medicines, amiloride can have side effects, which the study team will fully explain. All reasonable precautions will be taken to minimise any risks and monitor your health closely. Remember, you can always change your mind and leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'nephrogenic diabetes insipidus'?

It's a kidney problem, sometimes caused by long-term lithium use, where your kidneys can't properly concentrate your urine. This makes you very thirsty and needing to pass urine often.

What is amiloride?

Amiloride is a medicine that can help your kidneys hold onto water, potentially reducing thirst and frequent urination for people with this kidney problem.

Will I know if I'm getting the real medicine or a dummy pill?

No, during the study, neither you nor the study team will know if you are receiving amiloride or a placebo (dummy pill). This helps ensure fair results.

How long will I need to be in the study?

If you join, the study will involve daily treatment for 2 months, with follow-up appointments and checks for a total of 12 months.

What kind of tests will I have?

You will have blood tests, urine tests, and fill out questionnaires about how you are feeling, your thirst, and your quality of life.