Depressive Disorder, MajorPhase 4NCT00220636
Abilify as an Adjunctive Treatment for Refractory Depression
A Phase 4 study testing Aripiprazole in people with Depressive Disorder, Major, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jan 2008
- 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 and female outpatients between the ages of 18 and 70.
- Patients with a principal Diagnostic and Statistical Manual fourth edition (DSM-IV) diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type
- Patients with a total of 14 or higher on the 17-item Hamilton Depression Scale at baseline
- Patients who have had treatment with an SSRI at an adequate dose (see Table for a minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in Table 2)
- Patients who agree to use acceptable method of birth control throughout the study
Who cannot join
- Patients with any of the following DSM-IV diagnoses: Delirium, Dementia, Amnestic, or other Cognitive Disorders. Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder, Anorexia Nervosa, or Bulimia.
- Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol.
- Patients who are pregnant or nursing women.
- Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: (a) report of having a specific plan for killing themselves, (b) a score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, or (c) a suicide attempt within the last 6 months which required medical attention, such as an emergency room visit or which is considered by the treating physician to have been possibly life threatening
- Patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure>150/90), cardiovascular disease, diabetes, HIV (by report of patient).
- Patients with a history of seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Evaluation Service, NY State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression
This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.
Read the detailed description
This is a pilot study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. Fifteen subjects will be given aripiprazole in a flexible dosing schedule and followed for 12 weeks, while continuing their ongoing SSRI medication. Assessments of depressive symptoms, overall functioning, social functioning, and side effects will be completed. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.
- Conditions
- Depressive Disorder, Major
- Being tested
- Aripiprazole
- Keywords
- Major Depression, Depression, Unipolar Depression, Treatment Resistant Depression, Adjunctive treatment
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group.
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Experimental | Aripiprazole 5 to 30 mg/day Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS)
Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression "responded" after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12.
Measured: 12 weeks
Secondary outcomes (3)
Clinical Global Impressions Improvement Scale (CGI)
clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)
Measured: 12 weeks
Change in Global Assessment of Functioning Scale (GAFS)
Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score.
Measured: baseline and 12 weeks
Change in Beck Depression Inventory (BDI) Score
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionMar 2007
- Study completionJan 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- David J. Hellerstein, MD, Principal investigator, NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220636
- Sponsor's protocol ID
- SLR-04-028
- Status last verified
- Oct 2014
- First submitted
- 21 Sep 2005
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hellerstein DJ. Aripiprazole as an adjunctive treatment for refractory major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1347-8. doi: 10.1016/j.pnpbp.2004.06.016. No abstract available.
PubMed 15588762
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression
- ClinicalTrials.gov ID
- NCT00220636
- Acronym / sponsor ID
- SLR-04-028
- Conditions
- Depressive Disorder, Major
- Keywords
- Major Depression, Depression, Unipolar Depression, Treatment Resistant Depression, Adjunctive treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Mar 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 20 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.
Detailed description
This is a pilot study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. Fifteen subjects will be given aripiprazole in a flexible dosing schedule and followed for 12 weeks, while continuing their ongoing SSRI medication. Assessments of depressive symptoms, overall functioning, social functioning, and side effects will be completed. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Experimental | Drug: AripiprazoleAripiprazole 5 to 30 mg/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female outpatients between the ages of 18 and 70.
- Patients with a principal Diagnostic and Statistical Manual fourth edition (DSM-IV) diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type
- Patients with a total of 14 or higher on the 17-item Hamilton Depression Scale at baseline
- Patients who have had treatment with an SSRI at an adequate dose (see Table for a minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in Table 2)
- Patients who agree to use acceptable method of birth control throughout the study
Key exclusion criteria (6 listed)
- Patients with any of the following DSM-IV diagnoses: Delirium, Dementia, Amnestic, or other Cognitive Disorders. Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder, Anorexia Nervosa, or Bulimia.
- Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol.
- Patients who are pregnant or nursing women.
- Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: (a) report of having a specific plan for killing themselves, (b) a score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, or (c) a suicide attempt within the last 6 months which required medical attention, such as an emergency room visit or which is considered by the treating physician to have been possibly life threatening
- Patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure>150/90), cardiovascular disease, diabetes, HIV (by report of patient).
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: AbilifyAripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group. | Drug | Aripiprazole |
Primary outcome
Hamilton Depression Rating Scale (HDRS)
Time frame: 12 weeks
Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression "responded" after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12.
3 secondary outcomes
Clinical Global Impressions Improvement Scale (CGI)
Time frame: 12 weeks
Change in Global Assessment of Functioning Scale (GAFS)
Time frame: baseline and 12 weeks
Change in Beck Depression Inventory (BDI) Score
Time frame: baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15588762Hellerstein DJ. Aripiprazole as an adjunctive treatment for refractory major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1347-8. doi: 10.1016/j.pnpbp.2004.06.016. No abstract available.
- Web Site for the Mood Disorders Research Program, with information about the study and the process of getting involved in research in general and specifically at our siteLink provided by the sponsor.
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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.
David J. Hellerstein, MD principal investigator
NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital 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 Aripiprazole in people with Depressive Disorder, Major, run by St. Luke's-Roosevelt Hospital 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 5 inclusion and 6 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 26 May 2016. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2015). 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?
Hamilton Depression Rating Scale (HDRS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00220636, which also lists 1 linked publication.
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 26 May 2016; AzTrials last refreshed its copy on 31 Oct 2026.