bupropion has been researched along with Behavior Disorders in 42 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.
| Excerpt | Relevance | Reference |
|---|---|---|
| "The authors reanalyzed data from the 17 placebo-controlled randomized controlled trials (N=8,027) of varenicline conducted by Pfizer, using complete intent-to-treat person-level longitudinal data to assess smoking abstinence and reports of suicidal thoughts and behavior, depression, aggression/agitation, and nausea and to compare effects in patients with (N=1,004) and without (N=7,023) psychiatric disorders." | 7.79 | Varenicline, smoking cessation, and neuropsychiatric adverse events. ( Gibbons, RD; Mann, JJ, 2013) |
| "To ensure safer use of bupropion, health professionals must respect the strict contraindications and warnings about use of this drug in patients with a history of seizures." | 7.74 | Serious adverse reactions of bupropion for smoking cessation: analysis of the French Pharmacovigilance Database from 2001 to 2004. ( Beyens, MN; Guy, C; Laporte, S; Mounier, G; Ollagnier, M, 2008) |
| "Escitalopram, which is a recently marketed selective serotonin reuptake inhibitors (SSRI), has no such reputation." | 5.33 | Sertraline, escitalopram and tianeptine related abnormal movements but not with bupropion: a case report. ( Akarsu, ES; Ayhan, IH; Cankurtaran, ES; Cekic, T; Ozalp, E; Palaoglu, O; Soygur, H; Turhan, L, 2006) |
| "Substantial concerns have been raised about the neuropsychiatric safety of the smoking cessation medications varenicline and bupropion." | 5.22 | Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. ( Anthenelli, RM; Ascher, J; Benowitz, NL; Evins, AE; Krishen, A; Lawrence, D; McRae, T; Russ, C; St Aubin, L; West, R, 2016) |
| "This descriptive, observational pilot study evaluated a smoking cessation intervention using open-label bupropion and nicotine replacement within an addiction treatment center for patients with high rates of comorbid psychiatric diagnoses." | 5.10 | Smoking cessation treatment among dually diagnosed individuals: preliminary evaluation of different pharmacotherapies. ( Baer, JS; Davis, TM; Fitzgibbons, K; Kivlahan, DR; Malte, CA; Saxon, AJ; Sloan, KL, 2003) |
| "The limited evidence available to date suggests that bupropion and varenicline are effective and tolerable for smoking cessation in adults with serious mental illnesses." | 4.93 | Efficacy and tolerability of pharmacotherapy for smoking cessation in adults with serious mental illness: a systematic review and network meta-analysis. ( Eden Evins, A; McNeill, A; Roberts, E; Robson, D, 2016) |
| " All forms of nicotine replacement therapy (NRT) -- gum, patches and inhaler -- and bupropion are safe and effective for increasing smoking cessation rates in the short and long terms." | 4.81 | The pharmacotherapy of smoking cessation. ( Morgan, LC; Peters, MJ, 2002) |
| "Varenicline and bupropion are effective smoking cessation treatments, but there are concerns about their safety in smokers with COPD." | 3.85 | Cardiovascular and neuropsychiatric risks of varenicline and bupropion in smokers with chronic obstructive pulmonary disease. ( Kotz, D; Sheikh, A; Simpson, CR; van Schayck, OCP; Viechtbauer, W; West, R, 2017) |
| "Bupropion is associated with a dose-dependent increased risk of seizures." | 3.85 | Concurrent Electroconvulsive Therapy and Bupropion Treatment. ( Geske, JR; Leung, JG; Murphy, LL; Palmer, BA; Takala, CR, 2017) |
| "Varenicline and bupropion are commonly prescribed non-nicotine containing smoking cessation agents." | 3.81 | Mental health status of varenicline and bupropion users during a quit attempt compared to current smokers, other quitters, and non-smokers. ( Borse, MS; Brown, JD; Li, C; Shewale, AR, 2015) |
| "Varenicline is an effective pharmacotherapy to aid smoking cessation." | 3.81 | Cardiovascular and neuropsychiatric risks of varenicline: a retrospective cohort study. ( Kotz, D; Sheikh, A; Simpson, C; van Schayck, OC; Viechtbauer, W; West, R, 2015) |
| "To investigate whether varenicline use was associated with increased risk of psychiatric adverse events, compared with bupropion, another drug used for smoking cessation." | 3.79 | Use of varenicline versus bupropion and risk of psychiatric adverse events. ( Hviid, A; Pasternak, B; Svanström, H, 2013) |
| "The authors reanalyzed data from the 17 placebo-controlled randomized controlled trials (N=8,027) of varenicline conducted by Pfizer, using complete intent-to-treat person-level longitudinal data to assess smoking abstinence and reports of suicidal thoughts and behavior, depression, aggression/agitation, and nausea and to compare effects in patients with (N=1,004) and without (N=7,023) psychiatric disorders." | 3.79 | Varenicline, smoking cessation, and neuropsychiatric adverse events. ( Gibbons, RD; Mann, JJ, 2013) |
| "To ensure safer use of bupropion, health professionals must respect the strict contraindications and warnings about use of this drug in patients with a history of seizures." | 3.74 | Serious adverse reactions of bupropion for smoking cessation: analysis of the French Pharmacovigilance Database from 2001 to 2004. ( Beyens, MN; Guy, C; Laporte, S; Mounier, G; Ollagnier, M, 2008) |
| "Among smokers with psychiatric disorders, younger age, female sex, history of substance use disorders, and proxy measures of nicotine dependence or psychiatric illness severity also predicted greater risk." | 2.90 | Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial. ( Anthenelli, RM; Benowitz, NL; Evins, AE; Gaffney, M; Krishen, A; Lawrence, D; McRae, T; Russ, C; St Aubin, L; West, R, 2019) |
| "Bupropion treatment was associated with a significant change in ADHD symptoms at the week-6 endpoint (42% reduction), which exceeded the effects of placebo (24% reduction)." | 2.70 | A controlled clinical trial of bupropion for attention deficit hyperactivity disorder in adults. ( Biederman, J; Comeau, S; Doyle, R; Girard, K; Monuteaux, MC; Parekh, A; Polisner, D; Prince, J; Solhkhah, R; Spencer, TJ; Wilens, TE, 2001) |
| "Treating tobacco dependence is effective in patients with SMI." | 2.46 | Smoking cessation in severe mental illness: what works? ( Banham, L; Gilbody, S, 2010) |
| "Commonly co-occurring psychiatric disorders are disruptive behavior disorder, anxiety, depression, bipolar disorder and substance use disorders." | 2.44 | Treating common psychiatric disorders associated with attention-deficit/hyperactivity disorder. ( Dewan, M; Faraone, SV; Kunwar, A, 2007) |
| "Individuals with mental illness are particularly disadvantaged by their use of tobacco, spending as much as 40% of their income on cigarettes." | 2.44 | Use of smoking cessation therapies in individuals with psychiatric illness : an update for prescribers. ( Campbell, LA; Kisely, S, 2008) |
| " They were given bupropion extended release and though varied with dosing and time to resolution, they recovered dramatically." | 1.91 | Can bupropion treat COVID-19-induced brain fog? A case series. ( Reinfeld, S, 2023) |
| "Pharmacotherapies for smoking cessation are widely prescribed, despite substantial concerns being raised regarding the potential increased risk of cardiovascular (CV) and neuropsychiatric adverse events associated with these treatments." | 1.56 | Cardiovascular and neuropsychiatric safety of smoking cessation pharmacotherapies in non-depressed adults: a retrospective cohort study. ( Bassett, K; Carney, G; Dormuth, CR; Maclure, M; Taylor, S, 2020) |
| "Escitalopram, which is a recently marketed selective serotonin reuptake inhibitors (SSRI), has no such reputation." | 1.33 | Sertraline, escitalopram and tianeptine related abnormal movements but not with bupropion: a case report. ( Akarsu, ES; Ayhan, IH; Cankurtaran, ES; Cekic, T; Ozalp, E; Palaoglu, O; Soygur, H; Turhan, L, 2006) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 5 (11.90) | 18.2507 |
| 2000's | 12 (28.57) | 29.6817 |
| 2010's | 22 (52.38) | 24.3611 |
| 2020's | 3 (7.14) | 2.80 |
| Authors | Studies |
|---|---|
| Ciccarone, D | 1 |
| Shoptaw, S | 1 |
| Reinfeld, S | 1 |
| Carney, G | 1 |
| Bassett, K | 1 |
| Maclure, M | 1 |
| Taylor, S | 1 |
| Dormuth, CR | 1 |
| Kotz, D | 2 |
| Viechtbauer, W | 2 |
| Simpson, CR | 1 |
| van Schayck, OCP | 1 |
| West, R | 4 |
| Sheikh, A | 2 |
| Takala, CR | 1 |
| Leung, JG | 1 |
| Murphy, LL | 1 |
| Geske, JR | 1 |
| Palmer, BA | 1 |
| Peckham, E | 1 |
| Brabyn, S | 1 |
| Cook, L | 1 |
| Tew, G | 1 |
| Gilbody, S | 2 |
| Castaldelli-Maia, JM | 1 |
| Loreto, AR | 1 |
| Guimarães-Pereira, BBS | 1 |
| Carvalho, CFC | 1 |
| Gil, F | 1 |
| Frallonardo, FP | 1 |
| Ismael, F | 1 |
| Andrade, AG | 1 |
| Ventriglio, A | 1 |
| Richter, KP | 1 |
| Bhugra, D | 1 |
| Westfall, NC | 1 |
| Coffey, BJ | 1 |
| Anthenelli, RM | 2 |
| Gaffney, M | 1 |
| Benowitz, NL | 2 |
| McRae, T | 2 |
| Russ, C | 2 |
| Lawrence, D | 2 |
| St Aubin, L | 2 |
| Krishen, A | 2 |
| Evins, AE | 2 |
| Pasternak, B | 1 |
| Svanström, H | 1 |
| Hviid, A | 1 |
| Hilliard, WT | 1 |
| Barloon, L | 1 |
| Farley, P | 1 |
| Penn, JV | 1 |
| Koranek, A | 1 |
| Gibbons, RD | 1 |
| Mann, JJ | 1 |
| Rausch, R | 1 |
| Shewale, AR | 1 |
| Borse, MS | 1 |
| Brown, JD | 1 |
| Li, C | 1 |
| Simpson, C | 1 |
| van Schayck, OC | 1 |
| Tidey, JW | 1 |
| Miller, ME | 1 |
| Álvarez Gutiérrez, FJ | 1 |
| Ferrer Galván, M | 1 |
| Ruiz Bernal, A | 1 |
| Medina Gallardo, JF | 1 |
| Romero Romero, B | 1 |
| Sáez Díaz, A | 1 |
| Romero Falcón, A | 1 |
| Roberts, E | 1 |
| Eden Evins, A | 1 |
| McNeill, A | 1 |
| Robson, D | 1 |
| Ascher, J | 1 |
| Lin, CP | 1 |
| Chu, CP | 1 |
| Liu, HC | 1 |
| Beyens, MN | 1 |
| Guy, C | 1 |
| Mounier, G | 1 |
| Laporte, S | 1 |
| Ollagnier, M | 1 |
| Stern, RG | 1 |
| Bellucci, D | 1 |
| Cursi-Vogel, N | 1 |
| Hughley, J | 1 |
| Elangovan, N | 1 |
| Banham, L | 1 |
| Leventhal, AM | 1 |
| Japuntich, SJ | 1 |
| Piper, ME | 1 |
| Jorenby, DE | 1 |
| Schlam, TR | 1 |
| Baker, TB | 1 |
| Meyer, TE | 1 |
| Taylor, LG | 1 |
| Xie, S | 1 |
| Graham, DJ | 1 |
| Mosholder, AD | 1 |
| Williams, JR | 1 |
| Moeny, D | 1 |
| Ouellet-Hellstrom, RP | 1 |
| Coster, TS | 1 |
| Gifford, EV | 1 |
| Tavakoli, S | 1 |
| Wang, R | 1 |
| Hagedorn, HJ | 1 |
| Hamlett-Berry, KW | 1 |
| Saxon, AJ | 1 |
| Baer, JS | 1 |
| Davis, TM | 1 |
| Sloan, KL | 1 |
| Malte, CA | 1 |
| Fitzgibbons, K | 1 |
| Kivlahan, DR | 1 |
| Hébert, R | 1 |
| Taylor, MA | 1 |
| Vaidya, NA | 1 |
| Ozalp, E | 1 |
| Soygur, H | 1 |
| Cankurtaran, ES | 1 |
| Turhan, L | 1 |
| Cekic, T | 1 |
| Akarsu, ES | 1 |
| Palaoglu, O | 1 |
| Ayhan, IH | 1 |
| Kunwar, A | 1 |
| Dewan, M | 1 |
| Faraone, SV | 1 |
| Kisely, S | 1 |
| Campbell, LA | 1 |
| Bras, M | 1 |
| Biederman, J | 2 |
| Hornig, M | 1 |
| Farnam, CR | 1 |
| Wilens, TE | 1 |
| Spencer, TJ | 1 |
| Girard, K | 1 |
| Doyle, R | 1 |
| Prince, J | 1 |
| Polisner, D | 1 |
| Solhkhah, R | 1 |
| Comeau, S | 1 |
| Monuteaux, MC | 1 |
| Parekh, A | 1 |
| Peters, MJ | 1 |
| Morgan, LC | 1 |
| Fernandez, F | 1 |
| Levy, JK | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital[NCT05045326] | 150 participants (Anticipated) | Interventional | 2021-05-30 | Recruiting | |||
| 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 | ||
| Metabolism-informed Care for Smoking Cessation[NCT03227679] | 82 participants (Actual) | Interventional | 2016-05-18 | Completed | |||
| Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients: Pragmatic Clinical Trial[NCT03230955] | 300 participants (Actual) | Interventional | 2017-05-02 | 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 |
13 reviews available for bupropion and Behavior Disorders
| Article | Year |
|---|---|
Understanding Stimulant Use and Use Disorders in a New Era.
Topics: Adrenergic alpha-2 Receptor Antagonists; Adult; Anticonvulsants; Behavior Therapy; Bupropion; Centra | 2022 |
Smoking cessation in severe mental ill health: what works? an updated systematic review and meta-analysis.
Topics: Antidepressive Agents, Second-Generation; Bupropion; Cost-Benefit Analysis; Drug Therapy, Combinatio | 2017 |
Bupropion diversion and misuse in the correctional facility.
Topics: Antidepressive Agents, Second-Generation; Bupropion; Drug Overdose; Humans; Mental Disorders; Prison | 2013 |
Smoking cessation and reduction in people with chronic mental illness.
Topics: Anxiety Disorders; Bipolar Disorder; Bupropion; Electronic Nicotine Delivery Systems; Humans; Mental | 2015 |
Efficacy and tolerability of pharmacotherapy for smoking cessation in adults with serious mental illness: a systematic review and network meta-analysis.
Topics: Bupropion; Humans; Mental Disorders; Nicotinic Agonists; Smoking Cessation; Tobacco Use Cessation De | 2016 |
Smoking cessation in severe mental illness: what works?
Topics: Adult; Behavior Therapy; Body Weight; Bupropion; Dopamine Uptake Inhibitors; Female; Healthcare Disp | 2010 |
Treating common psychiatric disorders associated with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Adrenergic Uptake Inhibitors; Antidepressive Agents, Second-Generation; Anxiety Disorder | 2007 |
Use of smoking cessation therapies in individuals with psychiatric illness : an update for prescribers.
Topics: Antidepressive Agents, Second-Generation; Bupropion; Cognitive Behavioral Therapy; Dopamine Uptake I | 2008 |
[Psychopharmacotherapy in psychiatric comorbidities among patients with chronic pain].
Topics: Amines; Analgesics; Anticonvulsants; Bupropion; Chronic Disease; Cyclohexanecarboxylic Acids; Dopami | 2007 |
Attention-deficit/hyperactivity disorder: a life-span perspective.
Topics: Adolescent; Adult; Age Factors; Antidepressive Agents, Tricyclic; Attention Deficit Disorder with Hy | 1998 |
Addressing comorbidity in adults with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Adrenergic beta-Antagonists; Adult; Antidepressive Agents, Tricyclic; Attention Deficit | 1998 |
The pharmacotherapy of smoking cessation.
Topics: Antidepressive Agents, Second-Generation; Bupropion; Chewing Gum; Contraindications; Female; Humans; | 2002 |
Psychopharmacotherapy of psychiatric syndromes in asymptomatic and symptomatic HIV infection.
Topics: Acquired Immunodeficiency Syndrome; Adult; Antidepressive Agents; Anxiety Disorders; Bupropion; Depr | 1991 |
5 trials available for bupropion and Behavior Disorders
| Article | Year |
|---|---|
Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial.
Topics: Adult; Bupropion; Cohort Studies; Double-Blind Method; Female; Humans; Internationality; Male; Menta | 2019 |
Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial.
Topics: Adolescent; Adult; Aged; Bupropion; Dopamine Uptake Inhibitors; Double-Blind Method; Female; Humans; | 2016 |
Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial.
Topics: Adolescent; Adult; Aged; Bupropion; Dopamine Uptake Inhibitors; Double-Blind Method; Female; Humans; | 2016 |
Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial.
Topics: Adolescent; Adult; Aged; Bupropion; Dopamine Uptake Inhibitors; Double-Blind Method; Female; Humans; | 2016 |
Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial.
Topics: Adolescent; Adult; Aged; Bupropion; Dopamine Uptake Inhibitors; Double-Blind Method; Female; Humans; | 2016 |
Isolating the role of psychological dysfunction in smoking cessation: relations of personality and psychopathology to attaining cessation milestones.
Topics: Adult; Bupropion; Counseling; Defense Mechanisms; Female; Humans; Male; Mental Disorders; Nicotine; | 2012 |
Smoking cessation treatment among dually diagnosed individuals: preliminary evaluation of different pharmacotherapies.
Topics: Adult; Bupropion; Counseling; Diagnosis, Dual (Psychiatry); Dopamine Uptake Inhibitors; Drug Therapy | 2003 |
A controlled clinical trial of bupropion for attention deficit hyperactivity disorder in adults.
Topics: Adult; Age Factors; Antidepressive Agents, Second-Generation; Attention Deficit Disorder with Hypera | 2001 |
24 other studies available for bupropion and Behavior Disorders
| Article | Year |
|---|---|
Can bupropion treat COVID-19-induced brain fog? A case series.
Topics: Brain; Bupropion; COVID-19; Dopamine; Humans; Mental Disorders | 2023 |
Cardiovascular and neuropsychiatric safety of smoking cessation pharmacotherapies in non-depressed adults: a retrospective cohort study.
Topics: Adolescent; Adult; Aged; Bupropion; Cardiovascular Diseases; Cohort Studies; Female; Humans; Male; M | 2020 |
Cardiovascular and neuropsychiatric risks of varenicline and bupropion in smokers with chronic obstructive pulmonary disease.
Topics: Adult; Bupropion; Cardiovascular Diseases; Dopamine Uptake Inhibitors; England; Female; Humans; Male | 2017 |
Concurrent Electroconvulsive Therapy and Bupropion Treatment.
Topics: Adult; Aged; Antidepressive Agents, Second-Generation; Bupropion; Case-Control Studies; Combined Mod | 2017 |
Smoking cessation treatment outcomes among people with and without mental and substance use disorders: An observational real-world study.
Topics: Adult; Brazil; Bupropion; Cognitive Behavioral Therapy; Combined Modality Therapy; Comorbidity; Fema | 2018 |
Medication Reconciliation: Making Bupropion Work After a "Bad Experience".
Topics: Adolescent; Bupropion; Dopamine Uptake Inhibitors; Humans; Male; Medication Reconciliation; Mental D | 2018 |
Use of varenicline versus bupropion and risk of psychiatric adverse events.
Topics: Adult; Benzazepines; Bupropion; Denmark; Dopamine Uptake Inhibitors; Female; Humans; Male; Mental Di | 2013 |
Varenicline, smoking cessation, and neuropsychiatric adverse events.
Topics: Adult; Aggression; Akathisia, Drug-Induced; Benzazepines; Bupropion; Depression; Female; Humans; Mal | 2013 |
[Abstinence rates among varenicline are highest].
Topics: Benzazepines; Bupropion; Humans; Mental Disorders; Quinoxalines; Smoking Cessation; Treatment Outcom | 2014 |
Mental health status of varenicline and bupropion users during a quit attempt compared to current smokers, other quitters, and non-smokers.
Topics: Adolescent; Adult; Aged; Bupropion; Cross-Sectional Studies; Female; Humans; Male; Mental Disorders; | 2015 |
Cardiovascular and neuropsychiatric risks of varenicline: a retrospective cohort study.
Topics: Adult; Bupropion; Cardiovascular Diseases; Depression; Dopamine Uptake Inhibitors; Female; Humans; M | 2015 |
Predictors of 10-year smoking abstinence in smokers abstinent for 1 year after treatment.
Topics: Adult; Bupropion; Dopamine Uptake Inhibitors; Female; Humans; Logistic Models; Lost to Follow-Up; Ma | 2016 |
Naltrexone + bupropion (Mysimba). Too risky for only modest weight loss.
Topics: Anti-Obesity Agents; Blood Pressure; Bupropion; Drug Combinations; Drug Interactions; Humans; Mental | 2015 |
Bupropion improved apathy in behavioral variant frontotemporal dementia: a case report.
Topics: Aged; Antidepressive Agents, Second-Generation; Apathy; Brain; Bupropion; Frontotemporal Dementia; H | 2016 |
Serious adverse reactions of bupropion for smoking cessation: analysis of the French Pharmacovigilance Database from 2001 to 2004.
Topics: Adolescent; Adult; Aged; Angioedema; Antidepressive Agents, Second-Generation; Bupropion; Cerebrovas | 2008 |
Clozapine-induced sialorrhea alleviated by bupropion--a case report.
Topics: Antidepressive Agents, Second-Generation; Antipsychotic Agents; Bupropion; Clozapine; Humans; Male; | 2009 |
Neuropsychiatric events in varenicline and nicotine replacement patch users in the Military Health System.
Topics: Adult; Aged; Benzazepines; Bupropion; Female; Hospitalization; Humans; Male; Mental Disorders; Middl | 2013 |
Tobacco dependence diagnosis and treatment in Veterans Health Administration residential substance use disorder treatment programs.
Topics: Adult; Aged; Antidepressive Agents, Second-Generation; Bupropion; Female; Humans; Male; Mental Disor | 2013 |
What's new in nicotine & tobacco research.
Topics: Acquired Immunodeficiency Syndrome; Adolescent; Alcohol Drinking; Behavior, Addictive; Bupropion; Do | 2004 |
Psychopathology in neuropsychiatry: DSM and beyond.
Topics: Adult; Aged; Antidepressive Agents, Second-Generation; Bupropion; Data Collection; Depressive Disord | 2005 |
Bupropion: a German review.
Topics: Bupropion; Germany; Humans; Mental Disorders; Pancreatitis; Smoking Cessation | 2005 |
Sertraline, escitalopram and tianeptine related abnormal movements but not with bupropion: a case report.
Topics: Adult; Bupropion; Citalopram; Dopamine Uptake Inhibitors; Dyskinesias; Humans; Male; Mental Disorder | 2006 |
Practical approaches to the treatment of social phobia.
Topics: Adrenergic beta-Antagonists; Behavior Therapy; Benzamides; Benzodiazepines; Bupropion; Clonazepam; C | 1994 |
Zyban: a new aid to smoking cessation treatment--will it work for psychiatric patients?
Topics: Antidepressive Agents, Second-Generation; Bupropion; Drug Interactions; Drug Therapy, Combination; H | 1999 |