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Study Summary
This trial is testing if ketamine and mindfulness therapy can help people with depression. #mentalhealth
- Depression
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have certain types of personality disorders that could make it difficult for you to receive treatment.Your body mass index (BMI) is higher than 32.You have a history of a condition called obstructive sleep apnea, which affects your breathing during sleep.You have difficulties with thinking or learning that would make it hard for you to take part in the study or complete the required tests.You have previously participated in a mindfulness-based program called MBCT or MBSR in a group setting.You currently have a problem with alcohol or drug addiction.You have already tried taking antidepressant medication for at least 6 weeks, but it didn't work for you.You have not had any bad reactions to ketamine in the past.You have a history of misusing or abusing ketamine, or have had a bad reaction to it in the past.You have attempted to harm yourself in the past month or currently have thoughts of hurting yourself.You have been diagnosed with major depressive disorder based on specific criteria from a diagnostic manual.You have been diagnosed with bipolar disorder, schizophrenia, any psychotic illness, active PTSD, dissociative disorders, current substance-induced mood disorder, OCD, eating disorder, or panic disorder.
- Group 1: Ketamine-MBCT Intervention
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 meets the criteria for entry into this medical experiment?
"The entry criteria for this medical trial stipulates that participants must be afflicted with depression, aged between 18 and 65 years old. A total of 21 individuals are required to complete the study in its entirety."
Is the Ketamine-MBCT Intervention considered reliable for patient care?
"The safety of the Ketamine-MBCT Intervention was rated highly at 3 points, as it has already achieved Phase 4 trial status and is approved for usage."
To what extent is the patient population participating in this experiment?
"Affirmative. Clinicaltrials.gov indicates that this research team is presently searching for participants, with the trial being initially posted on March 30th 2022 and last updated July 10th 2023. A total of 21 individuals are to be recruited from one medical centre."
Does this research study accommodate participants aged 35 or younger?
"This clinical trial is only for patients aged 18 to 65; those under eighteen or over the age of sixty-five should look at other trials. There are 213 and 1007 respective studies available in these categories."
Are there still opportunities available to volunteers for this clinical trial?
"Affirmative. According to the data posted on clinicaltrials.gov, this trial has been actively recruiting since March 30th 2022 and was recently updated on July 10th 2023. The medical study is looking for 21 participants who will be recruited from a single site."
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