Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2007-01-31
2018-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
TRIPLE
Study Groups
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1
Active iomazenil and ketamine
iomazenil
Given as IV infusion
2
placebo iomazenil and ketamine
iomazenil
saline IV infusion
Interventions
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iomazenil
Given as IV infusion
iomazenil
saline IV infusion
Eligibility Criteria
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Inclusion Criteria
* Male or female.
* Written informed consent.
Exclusion Criteria
* A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox).
* History of abnormal EEG.
* History of severe allergies or multiple adverse drug reactions.
* Any medication that could interfere with either the safety of the study and/or the outcome measures.
* Any other conditions which in the opinion of the investigator would preclude participation in the study.
* History of major psychiatric disorder in first degree relatives.
* Current substance abuse/dependency determined by urine toxicology.
* Treatment with medications with CNS effects.
* Treatment with benzodiazepines within one week prior to testing.
* Current treatment with medications with psychotropic effects.
* Education \< 10th grade.
* IQ \< 70, MR.
* Non-English speaking.
21 Years
45 Years
ALL
Yes
Sponsors
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National Alliance for Research on Schizophrenia and Depression
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Mohini Ranganathan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yale School of Medicine, Associate Professor
Locations
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VHA Connecticut
West Haven, Connecticut, United States
Countries
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Other Identifiers
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0508000517
Identifier Type: -
Identifier Source: org_study_id
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