Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: mixed salts amphetamine
Intervention description: adjunctive to ADT
Intervention MeSH terms: Amphetamine; Adderall
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      In this Phase 4 trial we will study the safety, tolerability and efficacy of mixed salts
      amphetamine (MSA), trade name Adderall, augmentation of antidepressant therapy for Major
      Depressive Disorder (MDD) in depressed outpatient adults who are taking an antidepressant but
      have not had complete resolution of their symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female outpatients between the ages of 18-70.

          2. 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.

          3. Current depressive episode must be at least 8 weeks in duration.

          4. Hamilton Depression Rating Scale 17 (HDRS-17) score ≥ 14 at both the screen and
             baseline visits.

          5. Subject must have been receiving an adequate, stable dose of ADT, based on
             Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire
             (MGH-ATRQ).

          6. Subject must be responding inadequately to his/her current monotherapy ADT in the
             current major depressive episode (MDE).

          7. Subjects must be able to read and understand English and be able to provide written
             informed consent.

          8. Subjects must be considered reliable, able to comply with protocol requirements and
             understand the risks and benefits, per the investigator's clinical judgment.

          9. 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:

          1. Inadequate response during the current episode to more than 3 adequate trials of an
             ADT, as defined by the MGH-ATRQ.

          2. Psychiatric hospitalization within the last 6 months.

          3. Presence of cognitive disorder(s), bipolar disorder, Axis II pathology or other
             condition that investigator believes would interfere with participation in the study.

          4. Substance use disorder, current (as defined by DSM-IV-TR SCID) or positive results on
             urine drug screen or laboratory blood tests.

          5. Risk to self or others.

          6. 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.

          7. 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).

          8. Allergies and/or adverse drug reactions to MSA.

          9. Failure to respond to an adequate trial of MSA adjunctive to ADT in the current
             episode.

         10. Subjects taking narcotics, herbal/homeopathic remedies and/or other substance with
             psychotropic activity, based upon clinical judgment of study investigator.

         11. Pregnant or breastfeeding women.

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