Back to resultsAdjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
mixed salts amphetamine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
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.
-
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.
-
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Group 1(A): Placebo/MSA
Group 2(B): MSA/MSA
Arm Description
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 controlled release (CR) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine extended release (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 (as in Phase I).
Phase I (3 weeks) 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 controlled release (CR) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine extended release (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 (as in Phase I).
Outcomes
Primary Outcome Measures
Change in Scores on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)
The CPFQ is a seven-item self-administered questionnaire with higher scores indicating increased impairment in cognitive and physical functioning; score range being 7-42.
Secondary Outcome Measures
Change in Scores of the Montgomery Asberg Depression Rating Scale (MADRS)
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 measure by the change ion the MADRS scores.
The MADRS is clinician-rated and consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology. The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression," 20 to 34 indicates "moderate depression," a score of 35 and greater indicates "severe depression." There is evidence that an improvement of two points or more on the MADRS is considered clinically relevant.
Change in Scores on the Quick Inventory of Depressive Symptomatology Self Report 16 (QIDS-SR-16)
The group 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.
16 items comprising 9 domains; each domain is scored from 0 to 3, with higher scores reflecting greater psychopathology. Total scores range from 0 to 27. Scoring procedure is to include ONLY the highest score on among the 4 sleep items (items 1 to 4); include ONLY the highest score among the 4 weight items (items 6 to 9); include ONLY the highest score on either of the 2 psychomotor items (15 and 16). The scores for these 3 domains are then added to the scores (0-3) for each of the 6 MDD symptom domains for a total score of 0-27.
Full Information
NCT ID
NCT02058693
First Posted
January 15, 2014
Last Updated
June 12, 2023
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02058693
Brief Title
Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Adjunctive, Flexible-Dose Mixed Salts Amphetamine in Adult Outpatients With Major Depressive Disorder (MDD) Responding Inadequately to Current Antidepressant Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Forty 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1(A): Placebo/MSA
Arm Type
Placebo Comparator
Arm Description
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 controlled release (CR) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine extended release (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 (as in Phase I).
Arm Title
Group 2(B): MSA/MSA
Arm Type
Active Comparator
Arm Description
Phase I (3 weeks) 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 controlled release (CR) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine extended release (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 (as in Phase I).
Intervention Type
Drug
Intervention Name(s)
mixed salts amphetamine
Other Intervention Name(s)
Adderall
Intervention Description
adjunctive to ADT
Primary Outcome Measure Information:
Title
Change in Scores on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)
Description
The CPFQ is a seven-item self-administered questionnaire with higher scores indicating increased impairment in cognitive and physical functioning; score range being 7-42.
Time Frame
Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)
Secondary Outcome Measure Information:
Title
Change in Scores of the Montgomery Asberg Depression Rating Scale (MADRS)
Description
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 measure by the change ion the MADRS scores.
The MADRS is clinician-rated and consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology. The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression," 20 to 34 indicates "moderate depression," a score of 35 and greater indicates "severe depression." There is evidence that an improvement of two points or more on the MADRS is considered clinically relevant.
Time Frame
Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)
Title
Change in Scores on the Quick Inventory of Depressive Symptomatology Self Report 16 (QIDS-SR-16)
Description
The group 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.
16 items comprising 9 domains; each domain is scored from 0 to 3, with higher scores reflecting greater psychopathology. Total scores range from 0 to 27. Scoring procedure is to include ONLY the highest score on among the 4 sleep items (items 1 to 4); include ONLY the highest score among the 4 weight items (items 6 to 9); include ONLY the highest score on either of the 2 psychomotor items (15 and 16). The scores for these 3 domains are then added to the scores (0-3) for each of the 6 MDD symptom domains for a total score of 0-27.
Time Frame
Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
-
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey N Goldstein, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy
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