Major Depressive DisorderPhase 4NCT01942187
A Comparison of Medication Augmentation and PST in the Treatment of Depression in Older Adults
A Phase 4 study testing Aripiprazole, Bupropion and Problem Solving Therapy in people with Major Depressive Disorder and Dysthymic Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder Not Otherwise Specified (NOS)
- What is being tested?
- Aripiprazole, Bupropion and Problem Solving Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 50-90, inclusive
- Current diagnosis of major depressive disorder or dysthymia
- Treatment with either citalopram 30/mg or duloxetine 60 mg/day (6 weeks total, with at least three weeks of treatment at that dose)
- Hamilton Rating Scale for Depression (HRSD) >= 14
- Willing and able to complete NP testing
- Willing and able to complete medical exam, EKG, blood tests, and urine screen
- Willing and able to give consent
Who cannot join
- Meets criteria for psychotic depression
- MMSE score <24
- Bipolar disorder, psychotic disorder, or OCD
- History of alcohol or drug dependence (excluding nicotine) within past six months
- Suicide attempt within past six months or HRSD item 2 score > 2
- Diagnosis of probable Alzheimer's disease
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- Diagnosis of probable vascular dementia
- Acute, severe, or unstable medical illness
- Patients in psychotherapy
- Diagnosis of Parkinson's Disease
- Blood glucose >200 and/or total cholesterol >250
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: A Comparison of Medication Augmentation and Problem Solving Therapy
The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication.
Read the detailed description
Depression is common in older adults, and antidepressant medication is only effective in about 60% of patients seeking treatment. The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication. If patients have not remitted at the end of the 6 week aripiprazole trial, the aripiprazole will be stopped and they will be started on bupropion for the remaining 6 weeks of the study. Both aripiprazole augmentation and bupropion augmentation in depressed older adults have been approved by the FDA. No study has compared the effectiveness of PST and medication augmentation strategies for depressed older adults who are non-responders to an adequate trial of antidepressant medication in the current episode of their depression.
- Conditions
- Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder Not Otherwise Specified (NOS)
- Being tested
- Aripiprazole, Bupropion, Problem Solving Therapy
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment.
BupropionDrug
Also called Wellbutrin
Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.
Problem Solving TherapyBehavioural
Weekly specialized psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Medication Augmentation | Active comparator | Medication augmentation with aripiprazole (Abilify) starting at 5mg/day, and increasing weekly in 5mg increments to a maximum of 15mg (10mg/day is the target dose). Under conditions of nonresponse after 6 weeks, aripiprazole will be switched for bupropion (Wellbutrin), starting at 150mg, and possibly increasing to 300mg after 2 weeks. Receives: Drug: Aripiprazole; Drug: Bupropion |
| Problem Solving Therapy | Active comparator | Treatment for 12 weeks with weekly sessions of Problem Solving Therapy, with a trained therapist. Receives: Behavioral: Problem Solving Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Psychiatric Rating Scale for Depression
The Hamilton Depression Rating Scale (HAM-D) is used as a way of determining a patient's level of depression before, during, and after treatment. The scoring is based on the first 17 list items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
Measured: 12 weeks
Secondary outcomes (1)
Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test
IQ test designed to assess specific and overall cognitive capabilities and is individually administered
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startAug 2013 (estimated)
- Primary completionDec 2015 (estimated)
- Study completionDec 2015
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bret Rutherford, New York State Psychiatric Institute
- Investigators
- Bret Rutherford, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942187
- Sponsor's protocol ID
- #6627
- Status last verified
- Apr 2019
- First submitted
- 10 Sep 2013
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Medication Augmentation and Problem Solving Therapy
- ClinicalTrials.gov ID
- NCT01942187
- Acronym / sponsor ID
- #6627
- Conditions
- Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder Not Otherwise Specified (NOS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Aug 2013 (estimated)
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication.
Detailed description
Depression is common in older adults, and antidepressant medication is only effective in about 60% of patients seeking treatment. The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication. If patients have not remitted at the end of the 6 week aripiprazole trial, the aripiprazole will be stopped and they will be started on bupropion for the remaining 6 weeks of the study. Both aripiprazole augmentation and bupropion augmentation in depressed older adults have been approved by the FDA. No study has compared the effectiveness of PST and medication augmentation strategies for depressed older adults who are non-responders to an adequate trial of antidepressant medication in the current episode of their depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication Augmentation | Active comparator | Drug: Aripiprazole, Drug: BupropionMedication augmentation with aripiprazole (Abilify) starting at 5mg/day, and increasing weekly in 5mg increments to a maximum of 15mg (10mg/day is the target dose). Under conditions of nonresponse after 6 weeks, aripiprazole will be switched for bupropion (Wellbutrin), starting at 150mg, and possibly increasing to 300mg after 2 weeks. |
| Problem Solving Therapy | Active comparator | Behavioral: Problem Solving TherapyTreatment for 12 weeks with weekly sessions of Problem Solving Therapy, with a trained therapist. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ages 50-90, inclusive
- Current diagnosis of major depressive disorder or dysthymia
- Treatment with either citalopram 30/mg or duloxetine 60 mg/day (6 weeks total, with at least three weeks of treatment at that dose)
- Hamilton Rating Scale for Depression (HRSD) >= 14
- Willing and able to complete NP testing
Key exclusion criteria (11 listed)
- Meets criteria for psychotic depression
- MMSE score <24
- Bipolar disorder, psychotic disorder, or OCD
- History of alcohol or drug dependence (excluding nicotine) within past six months
- Suicide attempt within past six months or HRSD item 2 score > 2
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 |
|---|---|---|
| AripiprazoleAlso: AbilifyMedication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment. | Drug | Medication Augmentation |
| BupropionAlso: WellbutrinMedication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment. | Drug | Medication Augmentation |
| Problem Solving TherapyWeekly specialized psychotherapy | Behavioural | Problem Solving Therapy |
Primary outcome
Hamilton Psychiatric Rating Scale for Depression
Time frame: 12 weeks
The Hamilton Depression Rating Scale (HAM-D) is used as a way of determining a patient's level of depression before, during, and after treatment. The scoring is based on the first 17 list items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
1 secondary outcome
Wechsler Abbreviated Scale of Intelligence (WASI) Matrix Reasoning Test
Time frame: 1 Day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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.
Bret Rutherford, MD principal investigator
New York State Psychiatric Institute
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 Aripiprazole, Bupropion and Problem Solving Therapy in people with Major Depressive Disorder and Dysthymic Disorder, run by New York State Psychiatric Institute 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 7 inclusion and 11 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: withdrawn, as of the sponsor's last update on 18 Apr 2019. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Hamilton Psychiatric Rating Scale for Depression (time frame: 12 weeks). 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 18 Apr 2019.