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CLINICAL TRIALS VERSION

The gold standard for making psychiatric diagnoses in clinical trials remains the SCID. However, in recent years the MINI has gained popularity due to shorter administration time. Both are used to assess carefully-designed inclusion/exclusion criteria using a structured interview format. Enrolling inappropriate participants can cause failed trials; while careful and accurate assessments to determine whether the trial’s specified inclusion/exclusion DSM-IV diagnostic criteria are met can be critical. A validation study reported on the MINI indicates that it is diagnostically over-inclusive, which can potentially impact the outcome of trials.

A new version of the SCID, the SCID-CT, has been developed in conjunction with i3 research specifically for clinical trials. It aims to retain the diagnostic accuracy of the SCID, while streamlining for efficiency and simpler navigation. It also provides customizable indication-specific configurations of the modules, so it can be easily tailored for use in specific studies. While the format of the SCID-CT has been simplified to make it easier to use, the study participant questions remain the same as those found in the SCID-RV.

Modified features of the SCID-CT include:

1) Only essential elements for drug indications that incorporate typical inclusion and exclusion criteria are included. 
2) Subtypes and specifiers have been eliminated.
3) Criteria ratings have been streamlined into a "-" and "+" format rather than “?” "1" "2" "3" used in the SCID-RV.
4) The Overview has been abridged to entail clinical trial relevant questions only. 

Download the attached PDF to view an illustrative excerpt of the SCID-CT template for Bipolar Depression.

Templates for various clinical-trial-indication-specific versions of the SCID-CT have been developed.  Currently templates exist for the following indications: Major Depressive Disorder, Bipolar Disorder, Manic, Bipolar Disorder, Depressed, Schizophrenia and Posttraumatic Stress Disorder.  Additional "exclusionary" SCID-CT templates have also been developed for clinical trials that use another diagnostic instrument for the inclusion criteria (e.g, for ADHD, a diagnosis not covered in the SCID) but wish to use the SCID to rule out excluded diagnoses such as Major Depression, Bipolar Disorder, Schizophrenia and Substance Use Disorders. SCID-CT templates are available for use under the arrangement of a commercial license.  Modifications of the SCID-CT for other DSM disorders can be made upon request.  However, an additional fee applies for development of a new template.

Since the SCID-CT is customized specifically to each clinical trial, the protocol or detailed inclusion/exclusion criteria for the study (e.g., duration requirements not in the DSM-IV, such as Major Depressive Episodes lasting a minimum of 4 weeks) and direct investigative contact information is required to be sent to Michael First, MD at scid4@columbia.edu.  Dr. First will assess the scope of the modifications to tailor the SCID-CT and provide an estimated date of delivery.  Concurrently, a commercial license request must be initiated and finalized for receipt of the SCID-CT.  Click here for commercial license information.  The commercial license fee is $20 per study subject, based on an estimate of the number of subjects to be screened for enrollment.  In most instances, there is no additional charge for a customized version of the SCID-CT with the exception of a $1,500 fee for studies with an estimated number less than 200.

Click here for information on how to reference the SCID-CT.