Study on Memantine Hydrochloride for Adolescents with Bipolar Disorder

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Memantine in adolescents who have been diagnosed with Bipolar Disorder. Bipolar Disorder is a mental health condition characterized by extreme mood swings, including emotional highs (mania or hypomania) and lows (depression). The study aims to evaluate how effective and safe Memantine is in managing manic symptoms, which are part of these mood swings, in young people aged 13 to 17 years.

Participants in the study will be randomly assigned to receive either Memantine or a placebo, which is a substance with no active medication. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving Memantine and who is receiving the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for up to 52 weeks, during which the participants’ symptoms and any side effects will be closely monitored.

The main goal of the study is to see if Memantine can help reduce the manic symptoms in adolescents with Bipolar Disorder. The researchers will also look at how long participants stay in the study without needing additional medication and whether there are any improvements in their overall condition over the course of the study. Safety and any potential side effects will be carefully recorded to ensure the well-being of all participants.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes a clinical evaluation to ensure a diagnosis of Bipolar Disorder (BD) and a review of symptom severity.

Participants must be between 13 and 17 years old and meet specific diagnostic criteria. A structured diagnostic assessment will be conducted.

2 baseline evaluation

A baseline evaluation is conducted to record initial symptoms. This includes the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions-Bipolar (CGI-BP) severity score.

Participants must have a YMRS score between 20 and 40 and a CGI-BP severity score between 4 and 6.

3 randomization and treatment initiation

Participants are randomly assigned to receive either memantine or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.

The medication is administered orally in the form of Memantine Accord 10 mg film-coated tablets.

4 treatment phase

The treatment phase lasts for 12 weeks. During this time, participants take the assigned medication daily.

The primary goal is to observe changes in manic symptoms, measured by the YMRS score.

5 evaluation of primary outcomes

The primary outcome is assessed by the change in YMRS score from the start of the trial to week 12.

Secondary outcomes include the time to dropout and the response of manic or mixed episodes.

6 extended observation

Participants are observed for up to 52 weeks to evaluate long-term effects and safety.

This includes monitoring for any adverse events and assessing overall improvement in symptoms.

7 final assessment

A final assessment is conducted to evaluate the overall efficacy and safety of the treatment.

This includes a comprehensive review of symptom changes and any side effects experienced during the trial.

Who Can Join the Study?

Must be a boy or girl aged 13-17 years at the start of the study.
Must have a diagnosis of Bipolar Disorder (BD), which can be Type I, Type II, Cyclothymic Disorder, or Unspecified. The symptoms should be mild to moderate, with current manic, mixed, or hypomanic symptoms. These symptoms should not be psychotic and must be confirmed by a clinical expert using a structured assessment called the Kiddie-Schedule for Affective Disorders and Schizophrenia for School-aged Children, Present and Lifetime version (K-SADS-PL).
Must have a Young Mania Rating Scale (YMRS) total score between 20 and 40 at the start of the study. This is a scale used to measure the severity of manic symptoms.
Must have a Clinical Global Impressions-Bipolar Disorder (CGI-BP) severity score between 4 and 6 at the start of the study. This score helps to assess the overall severity of the disorder.
Must agree to participate in the study and have a parent or legal representative sign a consent form.
If a girl is able to have children, she must have a negative urine pregnancy test at the start of the study and use effective birth control during the study.

Who Cannot Join the Study?

Individuals who do not have a diagnosis of Bipolar Disorder cannot participate. Bipolar Disorder is a mental health condition that causes extreme mood swings.
Participants must be adolescents, which generally means they are in their teenage years.
Both males and females are eligible, so gender is not a reason for exclusion.
Participants should not be part of a vulnerable population, which means they should not be in a group that needs special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ospedale Pediatrico Bambino Gesu’	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	02.11.2021

Trial locations

Investigated drugs:

Memantine Hydrochloride

Memantine is being studied for its potential to help manage manic symptoms in adolescents with Bipolar Disorder. It is typically used to treat symptoms of Alzheimer’s disease, but in this trial, researchers are exploring its effectiveness as a mood-stabilizing medication. The goal is to see if it can help reduce the intensity of manic episodes and provide a stabilizing effect on mood.

Investigated diseases:

Bipolar disorder

Bipolar Disorder – Bipolar Disorder is a mental health condition characterized by extreme mood swings that include emotional highs (mania or hypomania) and lows (depression). During manic episodes, individuals may feel overly happy, energetic, or irritable, and may engage in impulsive behaviors. Depressive episodes can cause feelings of sadness, hopelessness, and a lack of interest in activities. The mood swings can affect sleep, energy, activity, judgment, behavior, and the ability to think clearly. The disorder can vary in severity and duration, with some people experiencing more frequent and severe episodes than others. It typically requires ongoing management to help stabilize mood swings and improve quality of life.

Trial ID:

2024-516713-21-00

Protocol code:

GR-2018-12367476

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Memantine Hydrochloride for Adolescents with Bipolar Disorder

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