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Precedex for Schizophrenia (DEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03708315
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Dexmedetomidine Hydrochloride Drug: Normal saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: Safety and Efficacy of Intravenous Dexmedetomidine in the Treatment of Schizophrenia
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: Order 1
Subjects will be given an infusion of Dexmedetomidine Hydrochloride (Precedex)
Drug: Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride
Other Name: Precedex

Placebo Comparator: Order 2
Subjects will be given an infusion of placebo ( normal saline).
Drug: Normal saline
Normal Saline (Placebo)
Other Name: Saline

Primary Outcome Measures :
  1. Positive and Negative Symptom Scale [ Time Frame: 4-5 hours of infusion. ]
    PANSS-EC Change from Baseline

  2. 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.

Secondary Outcome Measures :
  1. Behavioral Activity Rating Scale (BARS) [ Time Frame: Change from Baseline after 4-5 hours infusion ]
    BARS Change

  2. Clinical Global Impressions-Improvement Scale (CGI-I) [ Time Frame: Change from Baseline after 4-5 hours infusion ]
    CGI Change

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03708315

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Contact: Harsimar Kaur, MBBS 2039747544
Contact: Kimberlee Forselius-Bielen, BA 2039747540

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United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
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Principal Investigator: Mohini Ranganathan, MD Yale University

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Responsible Party: Yale University Identifier: NCT03708315     History of Changes
Other Study ID Numbers: 2000023998
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

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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

Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action