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Adjunctive Mixed Salts Amphetamine (MSA) for Depressed Adults With Incomplete Response to Current Antidepressant Therapy (ADT)

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ClinicalTrials.gov Identifier: NCT02058693
Recruitment Status : Completed
First Posted : February 10, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief 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.

40 adult outpatients with MDD who failed at least one adequate trial of antidepressant monotherapy will be consented in a 63-day, cross-sequential, multicenter study comprising two treatment phases of 21 days each. The time frame from consent to baseline is 7 days. Patients will receive placebo or MSA in Phase 1, and in Phase 2, participants will receive MSA. There will also be a two-week follow up visit after the completion of Phase 2.

We hypothesize that MSA will be safe and well tolerated, and will improve the patient's response to their antidepressant and provide superior symptom relief to antidepressant alone. The primary outcome measure is the Massachusetts General Hospital Cognitive-Physical Function Questionnaire (MGH-CPFQ).


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: mixed salts amphetamine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Adjunctive, Flexible-Dose Mixed Salts Amphetamine (MSA) in Adult Outpatients With Major Depressive Disorder (MDD) Responding Inadequately to Current Antidepressant Therapy (ADT)
Study Start Date : December 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Group

Phase I (3 weeks) placebo adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlaflaxine XR 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).

Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT

Drug: mixed salts amphetamine
adjunctive to ADT
Other Name: Adderall

Active Comparator: MSA group

mixed salts amphetamine, adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlaflaxine XR 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).

Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT

Drug: mixed salts amphetamine
adjunctive to ADT
Other Name: Adderall




Primary Outcome Measures :
  1. Change in scores on the Massachusetts General Hospital Cognitive and Physical Functioning Questionaire [ Time Frame: 7 Weeks ]
    The group treated with mixed salt amphetamine (MSA) adjunctive to antidepressant therapy (ADT) will show a greater mean change from baseline to endpoint in total score as compared to the group treated with placebo(PBO) as measured by the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MDH-CPFQQ).


Secondary Outcome Measures :
  1. Change in scores on the Montgomery Asberg Depression Rating Scale [ Time Frame: 7 Weeks ]
    The group treated with mixed salt amphetamine (MSA) adjunctive to antidepressant therapy (ADT) will show a greater mean change from baseline to endpoint as compared to the group treated with placebo (PBO) adjunctive to ADT as measured by the change on the MADRS scores.

  2. Change in scores on the Quick Inventory of Depressive Symptomatology Self Report 16 [ Time Frame: 7 Weeks ]
    The group treated with mixed salt amphetamine (MSA) adjunctive to antidepressant therapy (ADT) will show statistically significant improvement in core residual symptoms of major depressive disorder (MDD) extant on monotherapy ADT as measured by the Quick Inventory of Depressive Symptomatology Self Report 16


Other Outcome Measures:
  1. Mixed salt amphetamine (MSA) adjunctive to ADT will demonstrate clinically acceptable safety and tolerability [ Time Frame: 7 Weeks ]
    Participants who received mixed salt amphetamine, adjunctive to antidepressant therapy (ADT) will demonstrate clinically acceptable safety and tolerability, compared to placebo, based on reported adverse events, significant changes in blood pressure, pulse, weight, electrocardiogram, and Rush Sexual Inventory.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058693


Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Corey N Goldstein, MD Rush University Medical Center

Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02058693     History of Changes
Other Study ID Numbers: CTHF-1
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Amphetamine
Psychotropic Drugs
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors