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Precedex for Schizophrenia (DEX)

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ClinicalTrials.gov Identifier: NCT03708315
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE October 12, 2018
First Posted Date  ICMJE October 17, 2018
Last Update Posted Date October 17, 2018
Estimated Study Start Date  ICMJE November 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • Positive and Negative Symptom Scale [ Time Frame: 4-5 hours of infusion. ]
    PANSS-EC Change from Baseline
  • Richmond Agitation Scale Score [ Time Frame: 4-5 hours of infusion. ]
    2) The optimal intravenous dose of dexmedetomidine in schizophrenia patients in terms of efficacy and safety in order to achieve arousable sedation (Richmond Agitation Scale Score of -2) that can be temporarily reversed by verbal stimulation.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • Behavioral Activity Rating Scale (BARS) [ Time Frame: Change from Baseline after 4-5 hours infusion ]
    BARS Change
  • Clinical Global Impressions-Improvement Scale (CGI-I) [ Time Frame: Change from Baseline after 4-5 hours infusion ]
    CGI Change
  • To determine any adverse effects on blood pressure, heart rate, or respiratory drive occurs before or coincident with the achievement of the aforementioned level of sedation. [ Time Frame: Monitoring throughout the 4-5 hours infusion. ]
    To determine any adverse effects on blood pressure, heart rate, or respiratory drive occurs before or coincident with the achievement of the aforementioned level of sedation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Precedex for Schizophrenia
Official Title  ICMJE Safety and Efficacy of Intravenous Dexmedetomidine in the Treatment of Schizophrenia
Brief Summary Agitation is characterized by excessive motor or verbal activity, irritability, uncooperativeness, threatening gestures, and, in some cases, aggressive or violent behavior. While agitation may have various underlying causes, patients with schizophrenia are especially vulnerable to acute episodes of agitation, especially during exacerbation of disease, and clinicians do not always diagnose these episodes early enough. Agitation associated with psychosis is a frequent reason for emergency department visits, and unless it is recognized early and managed effectively, it can rapidly escalate to potentially dangerous behaviors, including physical violence. Educating psychiatric professionals about the timely and accurate diagnosis of agitation among patients with schizophrenia or bipolar disorder and developing a well-tolerated easily administered medication will contribute to the prompt and effective management of this condition and could help reduce the risk of violent behavior and other undesirable outcomes. This study is designed to identify the ideal dose range and tolerability of I.V Dexmedetomidine as a prelude to testing a sublingual formulation for efficacy in patients with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
The subjects will be randomized and will get either an infusion of Precedex or infusion of Normal Saline.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE
  • Drug: Dexmedetomidine Hydrochloride
    Dexmedetomidine Hydrochloride
    Other Name: Precedex
  • Drug: Normal saline
    Normal Saline (Placebo)
    Other Name: Saline
Study Arms  ICMJE
  • Active Comparator: Order 1
    Subjects will be given an infusion of Dexmedetomidine Hydrochloride (Precedex)
    Intervention: Drug: Dexmedetomidine Hydrochloride
  • Placebo Comparator: Order 2
    Subjects will be given an infusion of placebo ( normal saline).
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ability to give informed consent.
  2. Male or female between 18 and 65 years of age, inclusive
  3. According to DSM-V meet criteria for Schizophrenia Spectrum and other Psychotic disorders.

Exclusion Criteria:

  1. Current significant medical condition or other comorbidities
  2. Current substance dependence
  3. Women who are pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Harsimar Kaur, MBBS 2039747544 Harsimar.Kaur@yale.edu
Contact: Kimberlee Forselius-Bielen, BA 2039747540 kimberlee.forselius@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03708315
Other Study ID Numbers  ICMJE 2000023998
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohini Ranganathan, MD Yale University
PRS Account Yale University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP