Order 1 for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Connecticut Mental Health Center, New Haven, CTSchizophrenia+1 MoreDexmedetomidine Hydrochloride - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether the drug Dexmedetomidine can help manage episodes of agitation among patients with schizophrenia.

Eligible Conditions
  • Schizophrenia
  • Schizoaffective Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
PTSD Reactivity Condition
1
Dexmedetomidine Intranasal
1
BXCL501

Study Objectives

6 Primary · 3 Secondary · Reporting Duration: Assessed prior to dosing, throughout study drug administration, and up to one week after drug administration

Assessed prior to dosing, throughout study drug administration, and up to one week after drug administration
Adverse Effects
Measured at screening, prior to administartion, approximately every 15 minutes post drug administration, and one day after drug administration
Blood pressure
Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Agitation-Calmness Scale (ACES)
Behavioral Activity Rating Scale (BARS)
Richmond Agitation Sedation Scale (RASS)
Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
Clinical Global Impressions-Improvement Scale (CGI-I)
Positive and Negative Symptom Scale Excited Component (PANSS-EC)
Hour 11
Heart rate variability
Skin conductance response (SCR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
PTSD Reactivity Condition
1
Dexmedetomidine Intranasal
1
BXCL501

Trial Design

2 Treatment Groups

Order 1
1 of 2
Order 2
1 of 2

Active Control

Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Order 1 · Has Placebo Group · Phase 2

Order 1
Drug
ActiveComparator Group · 1 Intervention: Dexmedetomidine Hydrochloride · Intervention Types: Drug
Order 2
Drug
PlaceboComparator Group · 1 Intervention: Placebos · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed prior to dosing, throughout study drug administration, and up to one week after drug administration

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,706 Previous Clinical Trials
20,476,087 Total Patients Enrolled
56 Trials studying Schizophrenia
3,633 Patients Enrolled for Schizophrenia
Mohini Ranganathan, MDPrincipal InvestigatorYale University
4 Previous Clinical Trials
59 Total Patients Enrolled
1 Trials studying Schizophrenia
21 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with Schizophrenia or Schizoaffective disorder according to the DSM-V.
References

Frequently Asked Questions

Who are the ideal candidates for this clinical trial?

"This psychiatric study is seeking around 50 individuals who have been diagnosed with schizophrenia and are between 18-65 years old." - Anonymous Online Contributor

Unverified Answer

Does this research include adults aged 45 and up?

"This study only allows patients that fall within a certain age range, being over 18 years old and younger than 65." - Anonymous Online Contributor

Unverified Answer

What condition is Order 1 typically employed against?

"Order 1 can be used to treat various diseases, including but not limited to ventilations, mechanical, and cyclic vomiting syndrome." - Anonymous Online Contributor

Unverified Answer

Is Order 1 a common medication studied in clinical trials?

"At this moment, there are 119 ongoing studies concerning Order 1 with 25 of them in Phase 3. The majority of research concerning Order 1 is being conducted in Karachi, Sindh; however, there are 221 total locations running studies for Order 1." - Anonymous Online Contributor

Unverified Answer

Are researchers still able to enroll new participants in this trial?

"From the information available on clinicaltrials.gov, it appears that this clinical trial is still recruiting patients. This study was first posted on March 9th, 2020, and was edited on July 22nd, 2022. They are looking for 50 patients total from 1 site." - Anonymous Online Contributor

Unverified Answer

What level of risk is associated with Order 1 for human users?

"Order 1's safety was evaluated as a 2. This is because, while there is data supporting safety, there is no information suggesting that Order 1 is an effective medication." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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