Major Depressive DisorderPhase 4NCT02058693
Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy
A Phase 4 study testing mixed salts amphetamine in people with Major Depressive Disorder, run by Rush University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- mixed salts amphetamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
- -
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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
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.
Read the 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).
- Conditions
- Major Depressive Disorder
- Being tested
- mixed salts amphetamine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixed salts amphetamineDrug
Also called Adderall
adjunctive to ADT
| Study group | Role | What they receive |
|---|---|---|
| Group 1(A): Placebo/MSA | Placebo comparator | 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). Receives: Drug: mixed salts amphetamine |
| Group 2(B): MSA/MSA | Active comparator | 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). Receives: Drug: mixed salts amphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)
Secondary outcomes (2)
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.
Measured: Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)
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.
Measured: Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startDec 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corey N Goldstein, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058693
- Sponsor's protocol ID
- CTHF-1
- Status last verified
- Jun 2023
- First submitted
- 15 Jan 2014
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02058693
- Acronym / sponsor ID
- CTHF-1
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(A): Placebo/MSA | Placebo comparator | Drug: mixed salts amphetaminePhase 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). |
| Group 2(B): MSA/MSA | Active comparator | Drug: mixed salts amphetaminePhase 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mixed salts amphetamineAlso: Adderalladjunctive to ADT | Drug | Group 1(A): Placebo/MSA, Group 2(B): MSA/MSA |
Primary outcome
Change in Scores on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)
Time frame: Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)
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.
2 secondary outcomes
Change in Scores of the Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)
Change in Scores on the Quick Inventory of Depressive Symptomatology Self Report 16 (QIDS-SR-16)
Time frame: Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey N Goldstein, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mixed salts amphetamine in people with Major Depressive Disorder, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scores on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) (time frame: Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.