Symptoms of Major Depressive Disorder Scale (SMDDS)

OVERVIEW

The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) has determined that the Symptoms of Major Depressive Disorder Scale (SMDDS) demonstrated adequate evidence of content validity and cross-sectional measurement properties (i.e., internal consistency reliability, test-retest reliability, convergent validity, and known-groups validity) to measure symptoms of major depressive disorder (MDD). The qualification statement supports the SMDDS as a measure of overall MDD symptoms in drug development. Further evaluation is needed on the instrument’s longitudinal measurement properties (e.g., ability to detect change) and the interpretation of clinically meaningful within-patient change in score. Sponsors seeking to use the SMDDS as a primary or secondary endpoint measure in confirmatory studies should discuss with the appropriate CDER review division. For additional details regarding FDA’s qualification statement, please visit FDA's Clinical Outcome Assessment Qualification Program site.

  • Measure name: Symptoms of Major Depressive Disorder Scale (SMDDS)

  • Version: 1.0

  • Number of items: 16

  • Target patient population: Patients 18 years and older who are being treated in ambulatory settings with a diagnosis of MDD

  • Concept of interest: Self-reported severity of the defining symptoms of MDD

  • Recall period: Past 7 days

  • Response scale: 5-level verbal rating scale

  • Mode of data collection: Electronic administration is recommended for the SMDDS and previous studies were conducted using web-based completion

SMDDS  ITEMS

USER MANUAL

Available with license


LANGUAGE AVAILABILITY

Available translations of the SMDDS can be obtained when licensing the measure.  To assure standardized translations, users are not permitted to translate the SMDDS without prior, written permission from the PRO Consortium.  Permission for additional translations or certification of additional countries for an existing translation are covered via an addendum to the license agreement.  If a country for an available language is needed for which the translation has not yet been certified, cognitive interviewing is to be conducted in each target country, with a minimum of 5 participants per language/country who match the target population for as many criteria as reasonably practical. Please contact us for more details.

PREFERRED TRANSLATION VENDOR FOR SMDDS
ICON Language Services

LICENSING
Licensing fees are assessed on a per trial/per measure basis for commercial use.​

  • ​PRO Consortium Member Firms:

    • First Language​                                                                                           $1000 USD

    • Each Additional/Available Language                                                        $500 USD

  • Non-Member Organizations​

    • First Language​                                                                                          $4000 USD

    • Each Additional/Available Language                                                      $2000 USD

 

Non-commercial use is assessed on a case-by-case basis for appropriateness and applicability.

To license an available version of the SMDDS, please complete the licensing form. All of the information provided in the form will be kept strictly confidential. For questions about the measure, please contact us.

PUBLICATIONS

McCarrier KP, Deal LS, Abraham L, Blum SI, Bush EN, Martin M, Thase ME, Coons SJ on behalf of the Patient-Reported Outcome Consortium’s Depression Working Group. Patient-centered research to support the development of the Symptoms of Major Depressive Disorder Scale (SMDDS): initial qualitative research. The Patient—Patient-Centered Outcomes Research 2016;9:117-134.

Bushnell DM, McCarrier KP, Bush EN, Abraham L, Jamieson C, McDougall F, Trivedi M, Thase M, Carpenter L, Coons SJ, on behalf of the Patient-Reported Outcome Consortium’s Depression Working Group. Symptoms of Major Depressive Disorder Scale (SMDDS):  performance of a novel patient-reported symptom measure.  Value in Health 2019;22:906-915.