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OLZ/SAM for Bipolar I Disorder
Study Summary
This trial will investigate the safety and tolerability of olanzapine and samidorphan in children with bipolar I disorder.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have been diagnosed with a serious alcohol or drug addiction in the past 3 months.You have a mental health condition that could make it difficult for you to take part in the study.Subjects who are receiving antipsychotic treatment for their medical condition, with a diagnosis of bipolar I disorder.You have had bad reactions or allergies to olanzapine or opioid antagonists in the past.You are currently taking medication for a mental health condition called bipolar I disorder.You are willing to abide by the contraception requirements for the duration of the study.You have taken clozapine or a long-acting injectable antipsychotic medication within the last 3 months.
- Group 1: Group 1 Olanzapine/ 5 mg Samidorphan
- Group 2: Group 2 Olanzapine/ 10mg Samidorphan
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who qualifies as an eligible participant for this clinical experiment?
"This clinical trial seeks 16 minors aged between 10 and 12 who have been diagnosed with Bipolar I Disorder. Applicants must weigh at least 70 pounds, be stable (as judged by the investigator), receiving antipsychotic treatment for their medical condition and willing to observe contraceptive measures throughout the duration of the study."
How many participants are being enrolled in this experiment?
"Correct. According to the data posted on clinicaltrials.gov, this medical examination is actively enrolling candidates. The experiment was initially announced on July 22nd 2021 and was recently updated as of October 5th 2021 - with a desire to recruit 16 individuals from two distinct venues."
Has the Food and Drug Administration certified OLZ/SAM for therapeutic use?
"With limited evidence for OLZ/SAM's safety and efficacy, it was rated a 1 on our Power team's scale."
Is this medical experiment accepting participants aged 55 and above?
"According to the trial's eligibility requirements, participants must be between 10 and 12 years old."
Is recruitment still open for this investigation?
"As per the clinicaltrials.gov website, candidates are being sought out for this medical trial. It was initially posted on July 22nd 2021 and underwent a most recent update on October 5th of the same year."
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