bupropion has been researched along with Mood Disorders in 12 studies
Bupropion: A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.
bupropion : An aromatic ketone that is propiophenone carrying a tert-butylamino group at position 2 and a chloro substituent at position 3 on the phenyl ring.
Mood Disorders: Those disorders that have a disturbance in mood as their predominant feature.
Excerpt | Relevance | Reference |
---|---|---|
"US Clinical Trials registration was systematically searched for studies examining the effects of dextromethorphan in mood disorders." | 9.41 | Combinations of dextromethorphan for the treatment of mood disorders - a review of the evidence. ( Iosifescu, DV; Parincu, Z, 2023) |
"The identification of nicotine dependence as a psychiatric disorder and increased knowledge of nicotine's neuropharmacologic effects have stimulated researchers to search for new pharmacologic interventions for smoking cessation." | 8.80 | Bupropion sustained release and smoking cessation. ( Goldstein, MG, 1998) |
"These naturalistic data suggest that bupropion is well tolerated and may be an effective medication for the treatment of substance abusing adolescents with comorbid mood disorders and ADHD." | 7.73 | Bupropion SR for the treatment of substance-abusing outpatient adolescents with attention-deficit/hyperactivity disorder and mood disorders. ( Biederman, J; Daly, J; Prince, JB; Solhkhah, R; Van Patten, SL; Wilens, TE, 2005) |
"US Clinical Trials registration was systematically searched for studies examining the effects of dextromethorphan in mood disorders." | 5.41 | Combinations of dextromethorphan for the treatment of mood disorders - a review of the evidence. ( Iosifescu, DV; Parincu, Z, 2023) |
"Data came from 8120 smokers willing to make a quit attempt, randomized to varenicline, bupropion, nicotine replacement therapy (NRT) or placebo in Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) between 30 November 2011 and 13 January 2015." | 5.27 | Factors associated with the efficacy of smoking cessation treatments and predictors of smoking abstinence in EAGLES. ( Anthenelli, RM; Benowitz, NL; Evins, AE; Krishen, A; Lawrence, D; Maravic, MC; McRae, T; Russ, C; St Aubin, L; West, R, 2018) |
"The identification of nicotine dependence as a psychiatric disorder and increased knowledge of nicotine's neuropharmacologic effects have stimulated researchers to search for new pharmacologic interventions for smoking cessation." | 4.80 | Bupropion sustained release and smoking cessation. ( Goldstein, MG, 1998) |
" Lorcaserin (Belviq(®)), phentermine/topiramate combination (Qsymia(®)), and bupropion/naltrexone combination have been demonstrated to be effective for the treatment of obesity, as an adjunct to a reduced-calorie diet and physical activity, although their absolute safety has yet to be established with more widespread use or longer use." | 3.79 | Therapies for obesity and medication-associated weight gain. ( Howland, RH, 2013) |
"These naturalistic data suggest that bupropion is well tolerated and may be an effective medication for the treatment of substance abusing adolescents with comorbid mood disorders and ADHD." | 3.73 | Bupropion SR for the treatment of substance-abusing outpatient adolescents with attention-deficit/hyperactivity disorder and mood disorders. ( Biederman, J; Daly, J; Prince, JB; Solhkhah, R; Van Patten, SL; Wilens, TE, 2005) |
" Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo." | 1.51 | Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis. ( Acevedo, LM; Apovian, CM; Dunayevich, E; Greenway, FL; McElroy, SL; Pi-Sunyer, X, 2019) |
"Tranylcypromine was effective in the treatment of 14 patients meeting both the National Institute of Mental Health and DSM-III-R criteria for winter depression." | 1.28 | Pharmacological responsiveness of winter depression. ( Del Medico, VJ; Dilsaver, SC; Jaeckle, S; Quadri, A, 1990) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 4 (33.33) | 18.2507 |
2000's | 1 (8.33) | 29.6817 |
2010's | 6 (50.00) | 24.3611 |
2020's | 1 (8.33) | 2.80 |
Authors | Studies |
---|---|
Parincu, Z | 1 |
Iosifescu, DV | 1 |
West, R | 1 |
Evins, AE | 1 |
Benowitz, NL | 1 |
Russ, C | 1 |
McRae, T | 1 |
Lawrence, D | 1 |
St Aubin, L | 1 |
Krishen, A | 1 |
Maravic, MC | 1 |
Anthenelli, RM | 1 |
Pi-Sunyer, X | 1 |
Apovian, CM | 1 |
McElroy, SL | 1 |
Dunayevich, E | 1 |
Acevedo, LM | 1 |
Greenway, FL | 1 |
Howland, RH | 1 |
Carvalho, MM | 1 |
Campos, FL | 1 |
Coimbra, B | 1 |
Pêgo, JM | 1 |
Rodrigues, C | 1 |
Lima, R | 1 |
Rodrigues, AJ | 1 |
Sousa, N | 1 |
Salgado, AJ | 1 |
Muheim, L | 1 |
Krivisky, K | 1 |
Ashkenazy, T | 1 |
Kronfeld-Schor, N | 1 |
Einat, H | 1 |
Solhkhah, R | 1 |
Wilens, TE | 1 |
Daly, J | 1 |
Prince, JB | 1 |
Van Patten, SL | 1 |
Biederman, J | 1 |
Labbate, LA | 1 |
Grimes, JB | 1 |
Hines, A | 1 |
Pollack, MH | 1 |
Ashton, AK | 1 |
Rosen, RC | 1 |
Goldstein, MG | 1 |
Dilsaver, SC | 1 |
Del Medico, VJ | 1 |
Quadri, A | 1 |
Jaeckle, S | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With[NCT01456936] | Phase 4 | 8,144 participants (Actual) | Interventional | 2011-11-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 12
Intervention | percentage of participants (Number) |
---|---|
Varenicline 1.0 mg BID | 33.5 |
Bupropion 150 mg BID | 22.6 |
NRT Patch | 23.4 |
Placebo | 12.5 |
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 12
Intervention | percentage of participants (Number) |
---|---|
Varenicline 1.0 mg BID | 38.0 |
Bupropion 150 mg BID | 26.1 |
NRT Patch | 26.4 |
Placebo | 13.7 |
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 12
Intervention | percentage of participants (Number) |
---|---|
Varenicline 1.0 mg BID | 29.2 |
Bupropion 150 mg BID | 19.3 |
NRT Patch | 20.4 |
Placebo | 11.4 |
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 24
Intervention | percentage of participants (Number) |
---|---|
Varenicline 1.0 mg BID | 21.8 |
Bupropion 150 mg BID | 16.2 |
NRT Patch | 15.7 |
Placebo | 9.4 |
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 24
Intervention | percentage of participants (Number) |
---|---|
Varenicline 1.0 mg BID | 25.5 |
Bupropion 150 mg BID | 18.8 |
NRT Patch | 18.5 |
Placebo | 10.5 |
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 24
Intervention | percentage of participants (Number) |
---|---|
Varenicline 1.0 mg BID | 18.3 |
Bupropion 150 mg BID | 13.7 |
NRT Patch | 13.0 |
Placebo | 8.3 |
"The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as normal, not at all ill on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as no change on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs." (NCT01456936)
Timeframe: Baseline to Week 24
Intervention | percentage of participants (Number) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 1 (N= 1986, 1974, 1986, 1982) | Week 2 (N= 1934, 1936, 1927, 1926) | Week 3 (N= 1880, 1892, 1880, 1863) | Week 4 (N= 1860, 1856, 1858, 1834) | Week 5 (N= 1828, 1816, 1822, 1802) | Week 6 (N= 1816, 1808, 1820, 1773) | Week 8 (N= 1758, 1756, 1755, 1738) | Week 10 (N= 1717, 1707, 1715, 1675) | Week 12 (N= 1558, 1572, 1540, 1492) | Week 13 (N= 1612, 16081602, 1575) | Week 16 (N= 1586, 1606, 1568, 1541) | Week 20 (N= 1563, 1573, 1523, 1510) | Week 24 (N= 1533, 1515, 1499, 1497) | |
Bupropion 150 mg BID | 93.2 | 90.8 | 89.8 | 88.0 | 86.5 | 86.5 | 83.6 | 81.7 | 75.1 | 76.7 | 76.7 | 75.0 | 72.3 |
NRT Patch | 94.6 | 90.5 | 88.7 | 87.1 | 85.5 | 85.1 | 82.8 | 80.4 | 72.2 | 75.2 | 73.9 | 72.2 | 71.1 |
Placebo | 95.1 | 91.2 | 87.9 | 86.3 | 85.4 | 84.1 | 81.9 | 79.2 | 71.3 | 74.9 | 73.4 | 71.7 | 71.1 |
Varenicline 1.0 mg BID | 94.2 | 90.8 | 88.3 | 86.6 | 85.7 | 85.2 | 82.4 | 80.6 | 72.9 | 75.9 | 74.2 | 73.4 | 71.8 |
"A responder to this endpoint requires the answer no to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?" (NCT01456936)
Timeframe: 24 Weeks
Intervention | percentage of participants (Number) | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | Week 21 | Week 22 | Week 23 | Week 24 | |
Bupropion 150 mg BID | 1.1 | 17.9 | 22.3 | 24.4 | 25.7 | 26.9 | 30.2 | 26.5 | 30.4 | 27.6 | 30.7 | 27.1 | 26.5 | 29.2 | 29.2 | 25.1 | 27.9 | 27.8 | 27.9 | 23.9 | 26.7 | 26.4 | 27.0 | 23.2 |
NRT Patch | 0.9 | 14.2 | 20.0 | 23.5 | 25.1 | 26.8 | 31.3 | 28.0 | 32.1 | 28.0 | 32.1 | 27.6 | 26.9 | 29.4 | 29.2 | 24.9 | 28.1 | 28.2 | 28.1 | 23.7 | 26.5 | 26.3 | 25.3 | 23.6 |
Placebo | 1.0 | 10.3 | 12.1 | 13.1 | 13.6 | 14.6 | 17.9 | 15.9 | 18.1 | 15.5 | 18.8 | 16.0 | 16.0 | 19.1 | 19.8 | 16.1 | 18.8 | 19.5 | 19.2 | 16.3 | 18.8 | 18.4 | 18.3 | 15.7 |
Varenicline 1.0 mg BID | 1.3 | 18.8 | 26.3 | 30.4 | 33.4 | 35.8 | 39.5 | 37.4 | 41.6 | 38.7 | 42.5 | 39.6 | 36.8 | 39.5 | 38.5 | 33.1 | 36.4 | 36.2 | 35.7 | 30.8 | 33.9 | 33.8 | 33.0 | 29.8 |
"A responder to this endpoint requires the answer no to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?" (NCT01456936)
Timeframe: 24 Weeks
Intervention | percentage of participants (Number) | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | Week 21 | Week 22 | Week 23 | Week 24 | |
Bupropion 150 mg BID | 1.0 | 21.3 | 26.6 | 27.7 | 29.8 | 31.4 | 35.2 | 31.0 | 34.9 | 31.0 | 34.1 | 30.5 | 30.7 | 33.5 | 33.2 | 28.5 | 31.9 | 31.3 | 31.2 | 27.5 | 30.3 | 29.9 | 30.6 | 26.0 |
NRT Patch | 1.2 | 15.5 | 22.1 | 25.9 | 27.8 | 30.4 | 35.1 | 31.4 | 34.8 | 31.1 | 34.9 | 30.4 | 29.9 | 32.0 | 32.4 | 28.1 | 31.4 | 31.7 | 31.2 | 26.3 | 29.3 | 29.0 | 28.3 | 27.0 |
Placebo | 1.5 | 11.4 | 13.6 | 14.5 | 14.9 | 15.9 | 19.2 | 16.7 | 19.0 | 16.9 | 20.8 | 17.8 | 17.2 | 20.4 | 21.3 | 18.2 | 20.1 | 20.8 | 20.8 | 18.2 | 20.1 | 20.3 | 20.3 | 17.4 |
Varenicline 1.0 mg BID | 1.7 | 20.9 | 30.0 | 34.3 | 38.4 | 41.0 | 44.4 | 42.3 | 47.1 | 42.4 | 46.6 | 44.4 | 41.1 | 44.5 | 43.8 | 37.2 | 40.7 | 40.9 | 39.9 | 35.1 | 38.1 | 38.7 | 37.6 | 33.6 |
"A responder to this endpoint requires the answer no to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?" (NCT01456936)
Timeframe: 24 Weeks
Intervention | percentage of participants (Number) | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | Week 21 | Week 22 | Week 23 | Week 24 | |
Bupropion 150 mg BID | 1.2 | 14.6 | 18.1 | 21.3 | 21.8 | 22.7 | 25.4 | 22.1 | 26.0 | 24.3 | 27.4 | 23.9 | 22.6 | 25.0 | 25.3 | 21.9 | 24.0 | 24.5 | 24.7 | 20.4 | 23.2 | 22.9 | 23.5 | 20.4 |
NRT Patch | 0.7 | 13.0 | 17.9 | 21.1 | 22.4 | 23.3 | 27.5 | 24.6 | 29.4 | 25.0 | 29.4 | 24.9 | 24.0 | 26.8 | 26.0 | 21.8 | 24.8 | 24.7 | 25.1 | 25.1 | 23.7 | 23.6 | 22.2 | 20.1 |
Placebo | 0.5 | 9.2 | 10.7 | 11.8 | 12.4 | 13.4 | 16.6 | 15.0 | 17.2 | 14.0 | 17.2 | 14.2 | 14.8 | 17.8 | 18.3 | 13.9 | 17.4 | 18.2 | 17.6 | 17.6 | 17.5 | 16.5 | 16.4 | 14.0 |
Varenicline 1.0 mg BID | 1.0 | 16.8 | 22.7 | 26.6 | 28.5 | 30.8 | 34.8 | 32.7 | 36.2 | 35.1 | 38.6 | 35.0 | 32.7 | 34.7 | 33.4 | 29.1 | 32.3 | 31.7 | 31.6 | 26.6 | 29.7 | 29.1 | 28.5 | 26.1 |
"The primary safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | percentage of participants (Least Squares Mean) | |
---|---|---|
Non-psychiatric cohort (N=3984) | Psychiatric cohort (N= 4074) | |
Bupropion 150 mg BID | 2.44 | 6.62 |
NRT Patch | 2.31 | 5.20 |
Placebo | 2.52 | 4.83 |
Varenicline 1.0 mg BID | 1.25 | 6.42 |
The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms. (NCT01456936)
Timeframe: Baseline to Week 24
Intervention | Units on a scale (Mean) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 1 (N= 1989, 1976, 1985, 1987) | Week 2 (N= 1938, 1937, 1931, 1929) | Week 3 (N= 1882, 1891, 1881, 1867) | Week 4 (N= 1858, 1854, 1863, 1831) | Week 5 (N= 1829, 1815, 1820, 1797) | Week 6 (N= 1816, 1807, 1821, 1771) | Week 8 (N= 1755, 1754, 1755, 1736) | Week 10 (N= 1717, 1709, 1716, 1669) | Week 12 (N= 1562, 1571, 1548, 1491) | Week 13 (N= 1610, 1608, 1603, 1570) | Week 16 (N= 1579, 1602, 1566, 1537) | Week 20 (N= 1555, 1569, 1525, 1509) | Week 24 (N= 1528, 1512, 1495, 1487) | |
Bupropion 150 mg BID | 5.61 | 5.06 | 4.60 | 4.39 | 4.16 | 4.05 | 4.10 | 3.86 | 3.79 | 3.66 | 3.77 | 3.73 | 3.80 |
NRT Patch | 4.95 | 4.74 | 4.48 | 4.31 | 4.08 | 4.01 | 3.96 | 4.00 | 3.78 | 3.71 | 3.78 | 3.72 | 3.82 |
Placebo | 5.05 | 4.80 | 4.38 | 4.39 | 4.14 | 4.09 | 4.12 | 4.04 | 3.95 | 3.70 | 3.82 | 3.75 | 3.62 |
Varenicline 1.0 mg BID | 5.03 | 4.68 | 4.31 | 4.15 | 3.94 | 3.82 | 3.82 | 3.85 | 3.64 | 3.60 | 3.67 | 3.65 | 3.62 |
The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms. (NCT01456936)
Timeframe: Baseline to Week 24
Intervention | Units on a scale (Mean) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 1 (N= 1026, 1017, 1015, 1015) | Week 2 (N= 1005, 1004, 996, 995) | Week 3 (N= 947, 961, 945, 926) | Week 4 (N= 935, 938, 929, 908) | Week 5 (N= 918, 918, 914, 895) | Week 6 (N= 917, 914, 912, 874) | Week 8 (N= 887, 893, 878, 859) | Week 10 (N= 864, 865, 864, 823) | Week 12 (N= 790, 803, 798, 749) | Week 13 (N= 813, 812, 814, 763) | Week 16 (N= 795, 805, 791, 748) | Week 20 (N= 784, 784, 763, 737) | Week 24 (N= 770, 764, 758, 729) | |
Bupropion 150 mg BID | 7.58 | 6.99 | 6.51 | 6.36 | 6.03 | 5.87 | 5.96 | 5.72 | 5.66 | 5.44 | 5.62 | 5.54 | 5.69 |
NRT Patch | 6.82 | 6.64 | 6.30 | 6.16 | 5.82 | 5.62 | 5.63 | 5.64 | 5.44 | 5.36 | 5.44 | 5.46 | 5.57 |
Placebo | 6.70 | 6.42 | 6.02 | 6.04 | 5.80 | 5.75 | 5.63 | 5.55 | 5.42 | 5.09 | 5.37 | 5.26 | 5.04 |
Varenicline 1.0 mg BID | 6.76 | 6.42 | 5.99 | 5.87 | 5.58 | 5.39 | 5.43 | 5.38 | 5.17 | 5.06 | 5.26 | 5.17 | 5.21 |
The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms. (NCT01456936)
Timeframe: Baseline to Week 24
Intervention | Units on a scale (Mean) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 1 (N= 984, 972, 989, 992) | Week 2 (N= 961, 954, 963, 970) | Week 3 (N= 935, 930, 936, 941) | Week 4 (N= 923, 916, 934, 923) | Week 5 (N= 911, 897, 906, 902) | Week 6 (N= 899, 893, 909, 897) | Week 8 (N= 868, 861, 877, 877) | Week 10 (N= 853, 844, 852, 846) | Week 12 (N= 772, 768, 750, 742) | Week 13 (N= 797, 796, 789, 807) | Week 16 (N= 784, 797, 775, 789) | Week 20 (N= 771, 785, 762, 772) | Week 24 (N= 758, 748, 737, 758) | |
Bupropion 150 mg BID | 3.58 | 3.07 | 2.64 | 2.36 | 2.24 | 2.18 | 2.16 | 1.96 | 1.83 | 1.85 | 1.90 | 1.93 | 1.87 |
NRT Patch | 3.06 | 2.84 | 2.63 | 2.46 | 2.32 | 2.40 | 2.28 | 2.33 | 2.01 | 2.01 | 2.09 | 1.97 | 2.01 |
Placebo | 3.38 | 3.20 | 2.77 | 2.77 | 2.48 | 2.48 | 2.64 | 2.57 | 2.46 | 2.38 | 2.34 | 2.31 | 2.25 |
Varenicline 1.0 mg BID | 3.26 | 2.91 | 2.61 | 2.40 | 2.29 | 2.23 | 2.17 | 2.29 | 2.07 | 2.11 | 2.05 | 2.10 | 2.01 |
"The primary safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | percentage of participants (Number) | ||
---|---|---|---|
Non-psychiatric cohort (N= 990, 989, 1006, 999) | Psychiatric cohort (N= 1026, 1017, 1016, 1015) | Overall (N= 2016, 2006, 2022, 2014) | |
Bupropion 150 mg BID | 2.2 | 6.7 | 4.5 |
NRT Patch | 2.5 | 5.2 | 3.9 |
Placebo | 2.4 | 4.9 | 3.7 |
Varenicline 1.0 mg BID | 1.3 | 6.5 | 4.0 |
"The primary safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | percentage of participants (Number) | ||
---|---|---|---|
Non-psychiatric cohort (N= 990, 989, 1006, 999) | Psychiatric cohort (N= 1026, 1017, 1016, 1015) | Overall (N= 2016, 2006, 2022, 2014) | |
Bupropion 150 mg BID | 0.4 | 1.4 | 0.9 |
NRT Patch | 0.3 | 1.4 | 0.8 |
Placebo | 0.5 | 1.3 | 0.9 |
Varenicline 1.0 mg BID | 0.1 | 1.4 | 0.7 |
The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below. (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Anxiety | Depression | Feeling Abnormal | Hostility | Agitation | Aggression | Delusions | Hallucination | Mania | Panic Disorder | Paranoia | Psychosis | Homicidal Ideation | Suicidal Behavior | Suicidal Ideation | Suicide | |
Bupropion 150 mg BID | 5 | 4 | 1 | 1 | 40 | 12 | 1 | 4 | 10 | 20 | 1 | 2 | 0 | 2 | 3 | 0 |
NRT Patch | 6 | 7 | 0 | 1 | 40 | 9 | 2 | 2 | 5 | 14 | 0 | 4 | 1 | 1 | 5 | 0 |
Placebo | 5 | 6 | 0 | 0 | 33 | 11 | 0 | 2 | 8 | 10 | 2 | 1 | 0 | 1 | 5 | 1 |
Varenicline 1.0 mg BID | 5 | 7 | 0 | 0 | 35 | 17 | 1 | 6 | 7 | 7 | 1 | 4 | 0 | 1 | 5 | 0 |
"The NPS AE endpoint was the occurrence of at least 1 treatment-emergent severe AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent severe AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Anxiety | Depression | Feeling Abnormal | Hostility | Agitation | Aggression | Delusions | Hallucination | Mania | Panic Disorder | Paranoia | Psychosis | Suicidal Behavior | Suicidal Ideation | Suicide | Homicidal Ideation | |
Bupropion 150 mg BID | 5 | 4 | 1 | 1 | 1 | 2 | 0 | 1 | 1 | 2 | 1 | 2 | 2 | 0 | 0 | 0 |
NRT Patch | 6 | 7 | 0 | 1 | 6 | 0 | 0 | 0 | 0 | 1 | 0 | 4 | 0 | 1 | 0 | 1 |
Placebo | 5 | 6 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 0 | 1 | 0 |
Varenicline 1.0 mg BID | 5 | 7 | 0 | 0 | 1 | 2 | 0 | 0 | 2 | 0 | 1 | 4 | 1 | 1 | 0 | 0 |
"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Anxiety (severe) | Depression (severe) | Feeling abnormal (severe only) | Hostility (severe) | Agitation (moderate and severe) | Aggression (moderate and severe) | Delusions (moderate and severe) | Hallucinations (moderate and severe) | Mania (moderate and severe) | Panic (moderate and severe) | Paranoia (moderate and severe) | Psychosis (moderate and severe) | Homicidal ideation (moderate and severe) | Suicidal behavior (moderate and severe) | Suicidal ideation (moderate and severe) | Suicide (moderate and severe) | |
Bupropion 150 mg BID | 1 | 0 | 0 | 1 | 11 | 3 | 0 | 0 | 1 | 4 | 1 | 0 | 0 | 1 | 1 | 0 |
NRT Patch | 0 | 0 | 0 | 1 | 19 | 2 | 1 | 0 | 2 | 1 | 0 | 1 | 1 | 1 | 2 | 0 |
Placebo | 3 | 0 | 0 | 0 | 11 | 3 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 0 | 3 | 1 |
Varenicline 1.0 mg BID | 0 | 1 | 0 | 0 | 10 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Anxiety (severe) | Depression (severe) | Feeling abnormal (severe only) | Hostility (severe) | Agitation (moderate and severe) | Aggression (moderate and severe) | Delusions (moderate and severe) | Hallucinations (moderate and severe) | Mania (moderate and severe) | Panic (moderate and severe) | Paranoia (moderate and severe) | Psychosis (moderate and severe) | Homicidal ideation (moderate and severe) | Suicidal behavior (moderate and severe) | Suicidal ideation (moderate and severe) | Suicide (moderate and severe) | |
Bupropion 150 mg BID | 4 | 4 | 1 | 0 | 29 | 9 | 1 | 4 | 9 | 16 | 0 | 2 | 0 | 1 | 2 | 0 |
NRT Patch | 6 | 7 | 0 | 0 | 21 | 7 | 1 | 2 | 3 | 13 | 0 | 3 | 0 | 0 | 3 | 0 |
Placebo | 2 | 6 | 0 | 0 | 22 | 8 | 0 | 2 | 6 | 7 | 2 | 1 | 0 | 1 | 2 | 0 |
Varenicline 1.0 mg BID | 5 | 6 | 0 | 0 | 25 | 14 | 1 | 5 | 7 | 7 | 1 | 4 | 0 | 1 | 5 | 0 |
"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Anxiety | Depression | Feeling abnormal | Hostility | Agitation | Aggression | Delusions | Hallucinations | Mania | Panic | Paranoia | Psychosis | Homicidal ideation | Suicidal behavior | Suicidal ideation | Suicide | |
Bupropion 150 mg BID | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
NRT Patch | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Placebo | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
Varenicline 1.0 mg BID | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Anxiety | Depression | Feeling abnormal | Hostility | Agitation | Aggression | Delusions | Hallucinations | Mania | Panic | Paranoia | Psychosis | Homicidal ideation | Suicidal behavior | Suicidal ideation | Suicide | |
Bupropion 150 mg BID | 4 | 4 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
NRT Patch | 6 | 7 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
Placebo | 2 | 6 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Varenicline 1.0 mg BID | 5 | 6 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides." (NCT01456936)
Timeframe: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | participants with positive responses (Number) | |||||
---|---|---|---|---|---|---|
Suicidal Behavior (Screening lifetime) | Suicidal Ideation (Screening lifetime) | Suicidal Behavior (Baseline) | Suicidal Ideation (Baseline) | Suicidal Behavior (treatment emergent 12 weeks) | Suicidal Ideation (treatment emergent 12 weeks) | |
Bupropion 150 mg BID | 9 | 43 | 0 | 1 | 0 | 4 |
NRT Patch | 7 | 50 | 0 | 0 | 1 | 3 |
Placebo | 6 | 49 | 0 | 1 | 1 | 6 |
Varenicline 1.0 mg BID | 6 | 48 | 0 | 0 | 0 | 7 |
"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides." (NCT01456936)
Timeframe: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | participants with positive responses (Number) | |||||
---|---|---|---|---|---|---|
Suicidal Behavior (Screening lifetime) | Suicidal Ideation (Screening lifetime) | Suicidal Behavior (Baseline) | Suicidal Ideation (Baseline) | Suicidal Behavior (treatment emergent 12 weeks) | Suicidal Ideation (treatment emergent 12 weeks) | |
Bupropion 150 mg BID | 152 | 400 | 0 | 6 | 1 | 19 |
NRT Patch | 118 | 383 | 0 | 2 | 1 | 23 |
Placebo | 129 | 398 | 1 | 4 | 3 | 31 |
Varenicline 1.0 mg BID | 143 | 386 | 0 | 6 | 0 | 34 |
"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides." (NCT01456936)
Timeframe: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Intervention | participants with positive responses (Number) | |||||
---|---|---|---|---|---|---|
Suicidal Behavior (Screening lifetime) | Suicidal Ideation (Screening lifetime) | Suicidal Behavior (Baseline) | Suicidal Ideation (Baseline) | Suicidal Behavior (treatment emergent 12 weeks) | Suicidal Ideation (treatment emergent 12 weeks) | |
Bupropion 150 mg BID | 143 | 357 | 0 | 5 | 1 | 15 |
NRT Patch | 111 | 333 | 0 | 2 | 0 | 20 |
Placebo | 123 | 349 | 1 | 3 | 2 | 25 |
Varenicline 1.0 mg BID | 137 | 338 | 0 | 6 | 0 | 27 |
2 reviews available for bupropion and Mood Disorders
Article | Year |
---|---|
Combinations of dextromethorphan for the treatment of mood disorders - a review of the evidence.
Topics: Adult; Bipolar Disorder; Bupropion; Depressive Disorder, Major; Depressive Disorder, Treatment-Resis | 2023 |
Bupropion sustained release and smoking cessation.
Topics: Administration, Cutaneous; Adult; Ambulatory Care; Bupropion; Clinical Trials as Topic; Delayed-Acti | 1998 |
2 trials available for bupropion and Mood Disorders
Article | Year |
---|---|
Factors associated with the efficacy of smoking cessation treatments and predictors of smoking abstinence in EAGLES.
Topics: Adult; Age Factors; Anxiety Disorders; Bupropion; Double-Blind Method; Ethnicity; Female; Humans; In | 2018 |
Topics: Adolescent; Adult; Aged; Anxiety Disorders; Bupropion; Cohort Studies; Comorbidity; Double-Blind Met | 2016 |
8 other studies available for bupropion and Mood Disorders
Article | Year |
---|---|
Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.
Topics: Anti-Obesity Agents; Bupropion; Double-Blind Method; Drug Combinations; Humans; Mood Disorders; Nalt | 2019 |
Therapies for obesity and medication-associated weight gain.
Topics: Animals; Appetite Depressants; Bariatric Surgery; Benzazepines; Bupropion; Chronic Disease; Combined | 2013 |
Behavioral characterization of the 6-hydroxidopamine model of Parkinson's disease and pharmacological rescuing of non-motor deficits.
Topics: Adrenergic Agents; Animals; Antidepressive Agents; Antiparkinson Agents; Behavior, Animal; Bupropion | 2013 |
Antidepressants reverse short-photoperiod-induced, forced swim test depression-like behavior in the diurnal fat sand rat: further support for the utilization of diurnal rodents for modeling affective disorders.
Topics: Animals; Antidepressive Agents; Bupropion; Choice Behavior; Circadian Rhythm; Disease Models, Animal | 2011 |
Bupropion SR for the treatment of substance-abusing outpatient adolescents with attention-deficit/hyperactivity disorder and mood disorders.
Topics: Adolescent; Adult; Attention Deficit Disorder with Hyperactivity; Bupropion; Child; Delayed-Action P | 2005 |
Bupropion treatment of serotonin reuptake antidepressant-associated sexual dysfunction.
Topics: 1-Naphthylamine; Adult; Antidepressive Agents; Antidepressive Agents, Second-Generation; Anxiety Dis | 1997 |
Bupropion as an antidote for serotonin reuptake inhibitor-induced sexual dysfunction.
Topics: Adult; Aged; Ambulatory Care; Anxiety Disorders; Bupropion; Dose-Response Relationship, Drug; Drug A | 1998 |
Pharmacological responsiveness of winter depression.
Topics: Adult; Antidepressive Agents; Bupropion; Depressive Disorder; Desipramine; Disorders of Excessive So | 1990 |