Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy

Inclusion Criteria

• Male or female outpatients between the ages of 18-70.
• Subject must meet criteria for single or recurrent, non-psychotic episode of MDD according to Diagnostic and Statistical Manual IV Text Revised (DSM-IV-TR) diagnosis, as determined by Structured Clinical Inventory of Depressive Symptoms (SCID) and confirmed by assessment of investigator.
• Current depressive episode must be at least 8 weeks in duration.
• Hamilton Depression Rating Scale 17 (HDRS-17) score ≥ 14 at both the screen and baseline visits.
• Subject must have been receiving an adequate, stable dose of ADT, based on Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire (MGH-ATRQ).
• Subject must be responding inadequately to his/her current monotherapy ADT in the current major depressive episode (MDE).
• Subjects must be able to read and understand English and be able to provide written informed consent.
• Subjects must be considered reliable, able to comply with protocol requirements and understand the risks and benefits, per the investigator's clinical judgment.
• Female subjects of childbearing potential must agree to use adequate form of birth control throughout the course of the study.

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Exclusion Criteria

• Inadequate response during the current episode to more than 3 adequate trials of an ADT, as defined by the MGH-ATRQ.
• Psychiatric hospitalization within the last 6 months.
• Presence of cognitive disorder(s), bipolar disorder, Axis II pathology or other condition that investigator believes would interfere with participation in the study.
• Substance use disorder, current (as defined by DSM-IV-TR SCID) or positive results on urine drug screen or laboratory blood tests.
• Risk to self or others.
• The presence of any medical condition, current or past, stable or unstable, that contraindicates the use of antidepressant medication or mixed amphetamine salts medication as determined by clinician's judgment.
• Clinically significant abnormal findings on physical exam, EKG or laboratory tests; current unstable, untreated hypertension in the opinion of the investigator; history of cerebrovascular accident (CVA) or seizure disorder (other than febrile childhood seizure).
• Allergies and/or adverse drug reactions to MSA.
• Failure to respond to an adequate trial of MSA adjunctive to ADT in the current episode.
• Subjects taking narcotics, herbal/homeopathic remedies and/or other substance with psychotropic activity, based upon clinical judgment of study investigator.
• Pregnant or breastfeeding women.

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