A study to compare the safety of ketamine hydrochloride and esketamine in healthy men for the treatment of depression

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What is this study about?

This study aims to compare how two different medications work in the body for the treatment of Depression. One medication is esketamine, which is given as a nasal spray. The other medication being studied is known as KET01, which is a ketamine hydrochloride prolonged release tablet, meaning the medicine is released slowly into the body over time after being swallowed.

Participants will take part in a process where they receive different treatments at different times. During the study, some individuals will receive the active medications, while others will receive a placebo. The research focuses on how well these substances are tolerated and how they move through the body, specifically looking at dissociative symptoms, which are feelings of being disconnected from one’s body or surroundings.

Who Can Join the Study?

You must be a male.
You must be at least 18 years old but no older than 45 years old when you sign the agreement to join the study.
You must be considered healthy after a full medical check-up, which includes a detailed review of your past medical history (your record of past illnesses and health issues).
Your Body Mass Index (a measurement used to see if your weight is healthy for your height) must be between 18.5 and 30.
You must weigh at least 50 kg (about 110 pounds).

Who Cannot Join the Study?

You cannot participate if you have any physical issues or medical conditions that might stop the study medicine from entering your body or working correctly, such as having had facial reconstruction (surgery to rebuild the face), rhinoplasty (nose reshaping surgery), or any major problems with the structure or function of your nose or airway, including nasal piercings.
You are excluded if you have obstructions (blockages) or mucosal lesions (sores or growths on the lining of the nose) in your nostrils or nasal passages.
You cannot join if you have had sinus surgery (surgery on the cavities in your skull around your nose) within the last 2 years.
You are ineligible if you show signs of rhinitis (inflammation or swelling of the inside of the nose, often causing sneezing or a runny nose) on the days you are meant to take the study medicine.
You cannot participate if you have any history of surgery that the doctor believes might affect how the medicine is absorbed into your system.
You are excluded if you have ever used ketamine, esketamine (including during medical anesthesia), or other dissociative drugs (medicines that can make you feel detached from your body or surroundings), such as PCP, Nitrous Oxide, or high doses of dextromethorphan (a common cough medicine).
You cannot join if you have any significant medical conditions affecting your cardiovascular (heart and blood vessels), pulmonary (lungs), gastrointestinal (stomach and intestines), hepatic (liver), renal (kidneys), hematological (blood), psychiatric (mental health), neurological (brain and nervous system), musculoskeletal (muscles and bones), endocrine (hormones), metabolic (how the body uses energy), or malignant (cancerous) systems, if the doctor believes these could put you at risk or change the study results.
You are excluded if your first-degree relatives (your parents, brothers, sisters, or children) have psychotic disorders (severe mental conditions involving loss of contact with reality) or bipolar disorders (conditions involving extreme mood swings).
You cannot participate if there is a family history of sudden cardiac death (unexpected death caused by heart failure) in your immediate family members.
You are ineligible if you have a history of alcohol use disorder or substance use disorder (addiction or problematic use of drugs), including benzodiazepines (anti-anxiety medications), opiates (strong pain relievers), hallucinogens (drugs that cause hallucinations), stimulants (drugs that increase body activity, like cocaine or amphetamines), or cannabis, unless it is just nicotine or caffeine.
You cannot join if you have a positive drug abuse test.
You are excluded if you have hypertension (high blood pressure), defined as a systolic (top number) reading of 140 mmHg or higher, or a diastolic (bottom number) reading of 90 mmHg or higher after resting for 5 minutes.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Charite Research Organisation GmbH	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	22.05.2023

Trial locations

Investigated drugs:

Ketamine Hydrochloride

Esketamine is a medication administered as a nasal spray that is used in this study to compare its effects and safety against an oral medication.

Ketamine is a medication provided in the form of tablets that are designed to release into the body slowly over time, and it is being tested to see how well it is tolerated when taken orally.

Investigated diseases:

Major depression

Depression – This condition is a mood disorder that causes a persistent feeling of sadness and a loss of interest in activities once enjoyed. It can affect how a person feels, thinks, and handles daily activities such as sleeping, eating, or working. The symptoms may develop gradually or appear suddenly following a stressful event. Over time, the emotional state can become increasingly heavy and difficult to manage. It often involves changes in brain chemistry that affect mood regulation.

Trial ID:

2023-503971-45-00

Protocol code:

KET01-03

Trial Phase:

Human Pharmacology (Phase I) – Other

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A study to compare the safety of ketamine hydrochloride and esketamine in healthy men for the treatment of depression

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?