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| ID | Type | Description | Link |
|---|---|---|---|
| TRD-1511-33321 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this research study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD).
Older adult participants with treatment-resistant depression will be randomly assigned to a Step 1 medication strategy.
If depression is not relieved at the end of 10 weeks, or if participants do not qualify for Step 1, participants will be randomly assigned to a Step 2 medication strategy:
All medication strategies will be offered in collaboration with participants' own physicians with the the research team providing support and guidance.
After treatment in Step 1 and/or Step 2, participants will enter the Continuation Phase to assess long term follow-up outcomes for 12 months.
Participants in this clinical trial will also be asked to participate in an additional study to gather imaging and biomarker data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole Augmentation | Experimental | Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects. |
|
| Bupropion Augmentation | Experimental | Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects. |
|
| Switch to Bupropion | Experimental | Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects. |
|
| Lithium Augmentation | Experimental | Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. |
|
| Switch to Nortriptyline | Experimental | Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole Augmentation | Drug | Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological Well-Being | Psychological well-being was assessed using the NIH Toolbox Psychological Wellbeing subscales of Positive Affect and General Life Satisfaction, with a T score calculated as the average of these two subscales. Higher scores indicate greater positive affect and life satisfaction. Reference T-score (mean=50, SD=10). | Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks |
| Number of Participants With Remission From Depression | Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms. | Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks |
| Serious Adverse Events | Life threatening illness, hospitalization, or need of medical care. | Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Lenze, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Late-Life Mood, Stress, and Wellness Research Program | Los Angeles | California | 90095 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41237789 | Derived | Oughli HA, Ainsworth NJ, Butters MA, Brown PJ, Gebara MA, Gettinger TR, Karp JF, Lavretsky H, Lenard E, Miller JP, Mulsant BH, Nicol GE, Reynolds CF 3rd, Yingling M, Lenze EJ; OPTIMUM Research Group. Cognitive changes in older adults receiving pharmacotherapy for treatment-resistant depression: a secondary analysis of the OPTIMUM randomised controlled trial. Lancet Healthy Longev. 2025 Oct;6(10):100767. doi: 10.1016/j.lanhl.2025.100767. Epub 2025 Nov 11. | |
| 38822571 |
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A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available through a Washington University in St. Louis (WUSTL) secure repository and registered at clinicaltrials.gov.
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Patients were recruited based on referrals from primary care providers (PCPs) or psychiatrists and self-referrals. This was further checked by using tools electronic medical records (EMRs) and using EMR-launched clinical decision tools. Print, radio, and social media advertising were used too. If patients self-referred, treatment recommendations were given by their community providers or a psychiatrist associated with the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole Augmentation | Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects. Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Step 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2019 | Aug 18, 2022 |
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|
|
| Bupropion Augmentation | Drug | Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects. |
|
|
| Switch to bupropion | Drug | Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects. |
|
|
| Lithium Augmentation | Drug | Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. |
|
|
| Switch to nortriptyline | Drug | Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml |
|
|
| Washington University School of Medicine Healthy Mind Lab |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Columbia University Adult and Late Life Depression Clinic | New York | New York | 10032 | United States |
| UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program | Pittsburgh | Pennsylvania | 15213 | United States |
| Centre for Addiction and Mental Health | Toronto | Ontario | M6J-1H4 | Canada |
| Derived |
| Srifuengfung M, Lenze EJ, Roose SP, Brown PJ, Lavretsky H, Karp JF, Reynolds CF 3rd, Yingling M, Sa-Nguanpanich N, Mulsant BH. Alcohol and substance use in older adults with treatment-resistant depression. Int J Geriatr Psychiatry. 2024 Jun;39(6):e6105. doi: 10.1002/gps.6105. |
| 36867173 | Derived | Lenze EJ, Mulsant BH, Roose SP, Lavretsky H, Reynolds CF 3rd, Blumberger DM, Brown PJ, Cristancho P, Flint AJ, Gebara MA, Gettinger TR, Lenard E, Miller JP, Nicol GE, Oughli HA, Pham VT, Rollman BL, Yang L, Karp JF. Antidepressant Augmentation versus Switch in Treatment-Resistant Geriatric Depression. N Engl J Med. 2023 Mar 23;388(12):1067-1079. doi: 10.1056/NEJMoa2204462. Epub 2023 Mar 3. |
| FG001 | Bupropion Augmentation | Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects. Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects. |
| FG002 | Switch to Bupropion | Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects. Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects. |
| FG003 | Lithium Augmentation | Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. |
| FG004 | Switch to Nortriptyline | Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml. Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml |
| COMPLETED | "Step 1" only includes: Aripiprazole Augmentation Bupropion Augmentation Switch to Bupropion |
|
| NOT COMPLETED |
|
|
| Step 2 |
|
|
In Participant Flow, Step 2 "milestones" shows numbers recorded for those who switched from Step 1 to Step 2, and the numbers for those who started Step 2 without having first participated in Step 1.
125 participants from the Step 1 arms (aripiprazole augmentation, bupropion augmentation, and switch to bupropion) also participated in Step 2.
A grand total of 742 unique participants were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole Augmentation | Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects. Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects. |
| BG001 | Bupropion Augmentation | Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects. Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects. |
| BG002 | Switch to Bupropion | Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects. Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects. |
| BG003 | Lithium Augmentation | Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. |
| BG004 | Switch to Nortriptyline | Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml. Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age for Step 1 participants | Step 1 had 619 participants enrolled | Mean | Standard Deviation | years |
| ||||||||
| Age, Customized | Age of Step 2 participants | Step 2 had 248 participants enrolled | Mean | Standard Deviation | years |
| ||||||||
| Sex: Female, Male | Step 1 participants | Step 1 totals for sex of participants enrolled | Count of Participants | Participants |
| |||||||||
| Sex: Female, Male | Step 2 participants | Step 2 sex of participants enrolled | Count of Participants | Participants |
| |||||||||
| Race/Ethnicity, Customized | Step 1 participants | Step 1 race/ethnicity of participants enrolled | Count of Participants | Participants |
| |||||||||
| Race/Ethnicity, Customized | Step 1 participants | Step 1 race/ethnicity of participants enrolled | Count of Participants | Participants |
| |||||||||
| Race/Ethnicity, Customized | Step 2 participants | Step 2 race/ethnicity of participants enrolled | Count of Participants | Participants |
| |||||||||
| Race/Ethnicity, Customized | Step 2 participants | Step 2 race/ethnicity of participants enrolled | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Psychological Well-Being | Psychological well-being was assessed using the NIH Toolbox Psychological Wellbeing subscales of Positive Affect and General Life Satisfaction, with a T score calculated as the average of these two subscales. Higher scores indicate greater positive affect and life satisfaction. Reference T-score (mean=50, SD=10). | Posted | Mean | 95% Confidence Interval | t-score | Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks |
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| Primary | Number of Participants With Remission From Depression | Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms. | Posted | Count of Participants | Participants | Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks |
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| Primary | Serious Adverse Events | Life threatening illness, hospitalization, or need of medical care. | Posted | Count of Participants | Participants | Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks |
|
Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole Augmentation | Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects. Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects. | 1 | 211 | 15 | 211 | 148 | 211 |
| EG001 | Bupropion Augmentation | Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects. Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects. | 1 | 206 | 15 | 206 | 120 | 206 |
| EG002 | Switch to Bupropion | Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects. Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects. | 1 | 202 | 19 | 202 | 136 | 202 |
| EG003 | Lithium Augmentation | Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. | 0 | 127 | 12 | 127 | 93 | 127 |
| EG004 | Switch to Nortriptyline | Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml. Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml | 0 | 121 | 11 | 121 | 93 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Hospitalization | Psychiatric disorders | Systematic Assessment |
| ||
| Non-psychiatric Hospitalization | General disorders | Systematic Assessment |
| ||
| Fall | General disorders | Systematic Assessment | required surgery/ER visit, but no known overnight hospitalization |
| |
| Other | General disorders | Systematic Assessment | includes instances of unrelated cancer and death to unrelated study cause |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Psychiatric disorders | Systematic Assessment | Unable to be still, and having the constant urge to move |
| |
| Headache | General disorders | Systematic Assessment |
| ||
| Reduced Salivation | General disorders | Systematic Assessment | dryness of mouth |
| |
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weight gain | General disorders | Systematic Assessment |
| ||
| Cold/Flu Symptoms | General disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Fall | General disorders | Systematic Assessment |
| ||
| Increased Appetite Without Weight Gain | General disorders | Systematic Assessment |
| ||
| Irritability or Emotional Lability | Psychiatric disorders | Systematic Assessment |
| ||
| Concenctration Difficulties | Psychiatric disorders | Systematic Assessment |
| ||
| Asthenia/Lassitude/Increased Fatiguability | General disorders | Systematic Assessment |
| ||
| Sleepiness/Sedation | General disorders | Systematic Assessment |
| ||
| Tension/Inner Unrest | General disorders | Systematic Assessment |
| ||
| Tremor | General disorders | Systematic Assessment |
| ||
| Polyuria/Polydipsia | Renal and urinary disorders | Systematic Assessment | frequent need to urinate/feeling of extreme thirstiness |
| |
| Increased Tendency to Sweating | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Lenze | Washington University in St. Louis | 314-362-5154 | lenzee@wustl.edu |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2022 | Sep 9, 2024 | SAP_004.pdf |
Not provided
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D016642 | Bupropion |
| D016651 | Lithium Carbonate |
| D009661 | Nortriptyline |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Lost to Follow-up |
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| Investigator discretion |
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| African American |
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| Other |
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| Other |
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| African American |
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| Other |
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| Other |
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| 10 weeks |
|
| ANOVA | 0.004 | augment with aripiprazole vs switch to bupropion | Superiority | Repeated measure of 2*2*3 ANOVA with age (60 - 70, > 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value < 0.05/3 it is significant. If the second lowest p-value is also < 0.05/2 then it also will be significant and if the third p-value is < 0.05 then it also will be significant. |
| ANOVA | 0.017 | augment with bupropion vs switch to bupropion | Superiority | Repeated measure of 2*2*3 ANOVA with age (60 - 70, > 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value < 0.05/3 it is significant. If the second lowest p-value is also < 0.05/2 then it also will be significant and if the third p-value is < 0.05 then it also will be significant. |
| Repeated measure of 2*2*3 ANOVA with age (60 - 70, > 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value < 0.05/3 it is significant. If the second lowest p-value is also < 0.05/2 then it also will be significant and if the third p-value is < 0.05 then it also will be significant. | ANOVA | 0.650 | Superiority |
| Repeated measure of 2*2*3 ANOVA with age (60 - 70, > 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value < 0.05/3 it is significant. If the second lowest p-value is also < 0.05/2 then it also will be significant and if the third p-value is < 0.05 then it also will be significant. | ANOVA | 0.003 | augmentation versus switch | Superiority |
| ANOVA | 0.385 | Superiority | For those who proceed to Step 2, analogous repeated measures 2*2*2 ANOVA will be used with a significance level of .05 for the time*treatment group comparison. |
| OG003 | Lithium Augmentation | Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. |
| OG004 | Switch to Nortriptyline | Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml. Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml |
|
|
|
| OG003 | Lithium Augmentation | Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. |
| OG004 | Switch to Nortriptyline | Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml. Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml |
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