bupropion has been researched along with Psychoses in 13 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 |
---|---|---|
"Bupropion was administered to a 45-year-old white man being treated for depression with psychosis." | 7.70 | Serum sickness induced by bupropion. ( Alao, AO; Armenta, WA; Yolles, JC, 1999) |
"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) |
" 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) |
" Exposure to bupropion during pregnancy (OR = 3." | 3.76 | Use of antidepressants during pregnancy and risk of attention-deficit/hyperactivity disorder in the offspring. ( Figueroa, R, 2010) |
"Bupropion was administered to a 45-year-old white man being treated for depression with psychosis." | 3.70 | Serum sickness induced by bupropion. ( Alao, AO; Armenta, WA; Yolles, JC, 1999) |
"Bupropion is an antidepressant drug also used as a smoking cessation aid, which inhibits norepinephrine and dopamine re-uptake." | 1.35 | Two acute psychotic episodes after administration of bupropion: a case of involuntary rechallenge. ( Baratta, A; Javelot, H; Javelot, T; Messaoudi, M; Nonnenmacher, C; Weiner, L; Westphal, JF, 2009) |
"A 29-year old had been admitted to our institution with acute onset of schizophreniform psychosis after 5-day administration of sustained-release bupropion hydrochloride, which had been prescribed for nicotine withdrawal in a daily dosage of 300 mg." | 1.32 | [Acute psychosis after administration of bupropion hydrochloride (Zyban)]. ( Livak, V; Neumann, M; Paul, HW, 2004) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 3 (23.08) | 18.7374 |
1990's | 3 (23.08) | 18.2507 |
2000's | 3 (23.08) | 29.6817 |
2010's | 4 (30.77) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
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 |
Fatemi, SH | 1 |
Yousefi, MK | 1 |
Kneeland, RE | 1 |
Liesch, SB | 1 |
Folsom, TD | 1 |
Thuras, PD | 1 |
Howland, RH | 1 |
Javelot, H | 1 |
Baratta, A | 1 |
Weiner, L | 1 |
Javelot, T | 1 |
Nonnenmacher, C | 1 |
Westphal, JF | 1 |
Messaoudi, M | 1 |
Figueroa, R | 1 |
Jaffe, R | 1 |
Leavitt, R | 1 |
Wind, T | 1 |
Neumann, M | 1 |
Livak, V | 1 |
Paul, HW | 1 |
Goode, DJ | 1 |
Manning, AA | 1 |
Clower, CG | 1 |
Stoll, AL | 1 |
Mayer, PV | 1 |
Kolbrener, M | 1 |
Goldstein, E | 1 |
Suplit, B | 1 |
Lucier, J | 1 |
Cohen, BM | 1 |
Tohen, M | 1 |
Yolles, JC | 1 |
Armenta, WA | 1 |
Alao, AO | 1 |
Fernandez, F | 1 |
Levy, JK | 1 |
Wright, G | 1 |
Galloway, L | 1 |
Kim, J | 1 |
Dalton, M | 1 |
Miller, L | 1 |
Stern, W | 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 | ||
Varenicline and Smoking Cessation in Schizophrenia[NCT01111149] | Phase 2 | 24 participants (Actual) | Interventional | 2009-12-31 | 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 |
Beck Depression Inventory (BDI), a self-report rating inventory measuring characteristic attitudes and symptoms of depression consisting of 21 items with each item rated on a four point scale (0=not present to 3=severe). The accepted ranges are as follows: 0 to 9 indicates no depression, 10 to 18 indicates mild to moderate depression, 19 to 29 indicates moderate to severe depression and 30 to 63 indicates severe depression. (NCT01111149)
Timeframe: Week 12
Intervention | units on a scale (Mean) |
---|---|
Sugar Pill | 3.71 |
Varenicline | 8.6 |
Bupropion HCl | 5.4 |
The value d' is a measure of the difference between the signal (non-X) and noise (X) distributions. As such, d' provides a means for assessing an individual's discriminative power since, in general, the greater the difference between the signal and noise distributions, the better the ability to distinguish and detect X and non-X stimuli. The lower the score, the better the detectability. Values shown below are for week 12. (NCT01111149)
Timeframe: Week 12
Intervention | unitless (Mean) |
---|---|
Sugar Pill | 0.71 |
Varenicline | 1.32 |
Bupropion HCl | 1.09 |
Beta represents an individual's response tendency: Some individuals are cautious and choose not to respond very often. Conceptually, such individuals want to make sure they are correct when they give a response. Higher values of Beta reflect this response style. The emphasis is on avoiding commission errors. Other individuals respond more freely to make sure they respond to most or all targets, and they tend to be less concerned about mistakenly responding to a non-target. Lower values of Beta are produced by this response style. Values shown below were obtained at week 12. (NCT01111149)
Timeframe: Week 12
Intervention | Beta (Mean) |
---|---|
Sugar Pill | 0.95 |
Varenicline | 1.41 |
Bupropion HCl | 2.92 |
Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12. (NCT01111149)
Timeframe: Week 12
Intervention | parts per million (Mean) |
---|---|
Sugar Pill | 21.14 |
Varenicline | 17 |
Bupropion HCl | 22.6 |
Number of cigarettes smoked at week 12 of the study by self-report. (NCT01111149)
Timeframe: Week 12
Intervention | number of cigarettes smoked (Mean) |
---|---|
Sugar Pill | 19.71 |
Varenicline | 9.4 |
Bupropion HCl | 17.1 |
"Variability of Standard Error (VSE) is a measure of response speed consistency. VSE measures within respondent variability. That is, the amount of variability the individual shows in 18 separate segments of the Continuous Performance Test in relation to his or her own overall standard error. Although VSE is a different measure than Overall Standard Error, typically the two measures produce comparable results. The higher the VSE, the greater the inconsistency in the response speed. The values shown below are the VSE for Week 12." (NCT01111149)
Timeframe: Week 12
Intervention | milliseconds (Mean) |
---|---|
Sugar Pill | 11.05 |
Varenicline | 11.38 |
Bupropion HCl | 11.8 |
Pulse will be measured. The values below were measured at week 12 of the study. (NCT01111149)
Timeframe: Week 12
Intervention | heart beats per minute (Mean) |
---|---|
Sugar Pill | 82.57 |
Varenicline | 87 |
Bupropion HCl | 89.2 |
Weight will be measured for each participant. Values listed below are for week 12. (NCT01111149)
Timeframe: Week 12
Intervention | lbs (Mean) |
---|---|
Sugar Pill | 218.39 |
Varenicline | 213.47 |
Bupropion HCl | 254.78 |
Abnormal Involuntary Movement Scale (AIMS), to assess abnormal involuntary movements associated with antipsychotic drugs. There are 10 questions, based on a five-point scale ranging from 0 (none) to 4 (severe). Items 11-14 are yes/no questions that have no impact on the score. The Total Score is the sum of questions 1-7 (minimum = 0; maximum = 28). The severity index consists of one question (item 8; rated 0=none to 4=severe) based on the rater's observation of abnormal movements The AIMS Global Score is the sum of three questions (each item rated 0=none to 4=severe) regarding abnormal movements overall (minimum score 0, maximum score 12). For the total score and subscores, the higher the score, the greater the severity of abnormal movements. Scoring is based on the chapter: Guy W (2000), Abnormal Involuntary Movement Scale (AIMS), in: Handbook of Psychiatric Measures (Rush AJ Jr, et al., eds). APA Publishing: Washington DC: pp. 166-167. (NCT01111149)
Timeframe: Week 12
Intervention | units on a scale (Mean) | ||
---|---|---|---|
AIMS Total (Week 12) | AIMS Severity Index (Week 12) | AIMS Global Score (Week 12) | |
Bupropion HCl | 1.40 | 0.4 | 0.6 |
Sugar Pill | 0.71 | 0 | 0 |
Varenicline | 1 | 0.2 | 0.2 |
"Barnes Akathisia Scale (BAS), a widely-used measurement of drug-induced akathisia. It consists of 4 questions with questions 1-3 scored on a scale of 0-3 with 0=normal and 3=severe (minimum score 0, maximum score 9; while item 4 is a global clinical assessment of akathisia rated on a scale of 0 (normal) to 5 (severe). The higher the score on each subsclae, the greater the severity of akathisia.~Simpson-Angus Scale (SAS), a 10-item instrument used to evaluate patients experiencing neuroleptic-induced parkinsonism and other extrapyramidal side effects. Items are rated for severity on a 0-4 scale, with 0 being normal and 4 being severe. Minimum = 0; Maximum = 40. The higher the score, the greater the severity." (NCT01111149)
Timeframe: Week 12
Intervention | units on a scale (Mean) | ||
---|---|---|---|
SAS (Week 12) | BAS Items 1-3 (Week 12) | BAS Item 4 (Week 12) | |
Bupropion HCl | 0.42 | 0.4 | 0.2 |
Sugar Pill | 0.2 | 0.57 | 0.29 |
Varenicline | 0.76 | 0.6 | 0.4 |
The Wisconsin Inventory of Smoking Dependence Motives (WISDM) consists of 68 items regarding smoking. Each item is rated on a scale of 1 (not true of me at all) to 7 (extremely true of me) leading to a minimum score of 68 and a maximum score of 476. The higher the score, the greater the dependence. Four of the items are grouped into a Craving subscale (minimum 4, maximum 28), the greater the score, the greater the craving. Five of the items are grouped into a Cognition subscale (minimum 5, maximum 35), the higher the score, the greater reliance on cigarette smoking for cognitive enhancement. WISDM scoring based on the original article by Piper et al., 2004. A multiple motives approach to tobacco dependence: the Wisconsin inventory of smoking dependence motives (WISDM-68). Journal of Consulting and Clinical Psychology 72:139-154. (NCT01111149)
Timeframe: Week 12
Intervention | units on a scale (Mean) | ||
---|---|---|---|
WISDM Total (Week 12) | WISDM Cognition (Week 12) | WISDM Craving (Week 12) | |
Bupropion HCl | 270.6 | 23.2 | 18 |
Sugar Pill | 229.14 | 11.57 | 15.14 |
Varenicline | 229.4 | 15.4 | 14.2 |
"Minnesota Nicotine Withdrawal Scale (MNWS), a patient-reported measure of nicotine withdrawal symptoms and cravings. Eight items are listed, including craving for cigarettes, irritability, frustration, or anger, anxiety, etc scored on a five point scale from 0 (normal) to 5 (severe). Patients are asked for responses for the past 24 hours and past seven days (minimum 0, maximum 32; for each subscale). The higher the score, the greater the dependence. Additionally, one question (minimum score 1, maximum score 4 measures the individual's confidence in resisting strong urges to smoke. The higher the score on this question, the greater the individual's confidence in resisting smoking urges.~The Fagerstrom Test for Nicotine Dependence measures nicotine dependence and consists of six questions with a total minimum score of 0 and a maximum score of 10. The higher the score, the greater the dependence on nicotine." (NCT01111149)
Timeframe: Week 12
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
FTND (Week 12) | MNWS 24 Hour Total (Week 12) | MNWS 7 day total (Week 12) | MNWS Resistance (Week 12) | |
Bupropion HCl | 4.4 | 6.60 | 5.80 | 2.4 |
Sugar Pill | 4.86 | 7.29 | 9.14 | 2.71 |
Varenicline | 5.2 | 8.2 | 11 | 3.4 |
Brief Psychiatric Rating Scale (BPRS), an 24-item scale measuring positive symptoms, general psychopathology, and affective symptoms commonly used for schizophrenia with each item rated on a scale of 1-7 with 1=not present and 7=severe. The minimum score is 24 and the maximum score is 168. We have used five subscales as recommended by Dingemans et al., 1995: Positive subscale (minimum score 6; maximum score 42); Negative subscale (minimum score 5; maximum score 35); Depressed subscale (minimum score 5; maximum score 35); Mania subscale (minimum score 6; maximum score 42); and Disorientation subscale (minimum score 2; maximum score 14) . For both the total score and the subscale scores, the higher the score, the greater the symptom severity. We used the BPRS version 4.0. Dingemans PMAJ, Linszen DH, Lenoir ME, Smeets RMW, 1995. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology 122:263-267. (NCT01111149)
Timeframe: Week 12
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
BPRS Total - Week 12 | BPRS Positive Subscale - Week 12 | BPRS Negative Subscale - Week 12 | BPRS Mania Subscale - Week 12 | BPRS Disorientation Subscale - Week 12 | BPRS Depression Subscale - Week 12 | |
Bupropion HCl | 31.6 | 8 | 7.4 | 8 | 2 | 6.2 |
Sugar Pill | 30 | 8.14 | 6 | 6.43 | 2 | 7.43 |
Varenicline | 34.2 | 9 | 6.4 | 6.4 | 2 | 10.4 |
The hit reaction time is the average speed of correct responses for the entire test given in milliseconds. The higher the score, the slower the speed. The standard error is a measure of response speed consistency. The higher the overall standard error, the greater inconsistency in the response speed. The values below were measured at week 12. (NCT01111149)
Timeframe: Week 12
Intervention | milliseconds (Mean) | |
---|---|---|
Hit Reaction Time (week 12) | Hit Reaction Time Standard Error (Week 12) | |
Bupropion HCl | 63.81 | 8.79 |
Sugar Pill | 42.44 | 7.20 |
Varenicline | 67.61 | 6.96 |
Impulsivity and inattention will be measured using the continuous performance test. Individuals were tasked with 359 items divided six blocks (59 in block 1, 60 in blocks 2-6). Omissions result from the failure to respond to target letters. CPT% Omissions measures the percentage of responses that qualify as omissions made during the test. Higher scores indicate increased inattention. Commissions result from responses given to non-targets. CPT% Commissions measures the percentage of responses that qualify as commissions made during the test. Higher scores indicate increased inattention. Perseverations result from reaction time less than 100 ms. CPT% Perseveration % measures the percentage of responses that qualify as perseverations made during the test. The higher the score, the greater impulsivity. (NCT01111149)
Timeframe: Week 12
Intervention | Percentage of responses (Mean) | ||
---|---|---|---|
CPT % Omissions (Week 12) | CPT % Commissions (Week 12) | Perseveration % (Week 12) | |
Bupropion HCl | 2.42 | 28.33 | 0.12 |
Sugar Pill | 5.62 | 36.11 | 0.57 |
Varenicline | 0.68 | 25 | 1.05 |
Scale for the Assessment of Negative Symptoms (SANS) a well-established test, used to assess the presence of psychosis or negative symptoms of schizophrenia. It consists of 25 questions rated on a scale of 0 (none) to 5 (severe). With a total score range of 0 to 125 points. There are 6 subscales: Affective Flattening or Blunting - (minimum, 0; maximum 35); Inappropriate Affect (minimum, 0; maximum 5); Alogia (minimum 0; maximum 25); Avolition-Apathy (minimum 0; maximum 20); Anhedonia-Asociality (minimum 0; maximum 25); Attention (minimum 0; maximum 15). Each subscale (except for Inappropriate Affect) contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 25). The global questions are included within the Total Composite score. In each case, the larger the score, the more severe the symptoms. (NCT01111149)
Timeframe: Week 12
Intervention | units on a scale (Mean) | |||||||
---|---|---|---|---|---|---|---|---|
SANS Total Composite (Week 12) | SANS Total Global (Week 12) | SANS Affective Flattening (Week 12) | SANS Alogia (Week 12) | SANS Avolition (Week 12) | SANS Anhedonia (Week 12) | SANS Attention (Week 12) | Inappropriate Affect (Week 12) | |
Bupropion HCl | 6.20 | 1.6 | 0.8 | 0 | 3.6 | 1.4 | 0 | 0.40 |
Sugar Pill | 5.86 | 1.71 | 1.57 | 0.71 | 2 | 1.57 | 0 | 0 |
Varenicline | 17.2 | 3.8 | 7 | 0.6 | 3 | 5.8 | 0.2 | 0.60 |
Scale for the Assessment of Positive Symptoms (SAPS), a well-established test, used to assess the presence of psychotic symptoms of schizophrenia. There are 34 items rated on a scale of 0-5 with 0=none and 5=severe for a minimum score of 0 and a maximum score of 170. There are 4 subscales: Hallucinations (minimum score 0; maximum score 35); Delusions (minimum score 0; maximum score 65); Bizarre Behavior (minimum score 0; maximum score 25); Positive Formal Thought Disorder (minimum score 0; maximum score 45). Each subscale contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 20). The values for the Global items are included in the Total Composite score. In each case, the higher the score, the greater the severity of symptoms. (NCT01111149)
Timeframe: Week 12
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
SAPS Total Composite Score - Week 12 | SAPS Total Global - Week 12 | SAPS Hallucinations - Week 12 | SAPS Delusions - Week 12 | SAPS Bizarre Behavior - Week 12 | SAPS Thought Disorder - Week 12 | |
Bupropion HCl | 10.6 | 1.8 | 3 | 3.8 | 0.4 | 3.4 |
Sugar Pill | 3.43 | 1.29 | 2 | 1.43 | 0 | 0 |
Varenicline | 7 | 1.2 | 2.2 | 4.2 | 0 | 0.6 |
Successful outcome will be defined as a 50% or greater reduction in self-reported cigarettes per day and a 30% greater reduction in carbon monoxide and cotinine levels. Measured at week 12 (NCT01111149)
Timeframe: Week 12
Intervention | participants (Number) | |||
---|---|---|---|---|
50% Reduction in Number of Cigarettes Smoked | 30% Reduction in Carbon Monoxide (Week 12) | 30% Reduction in Serum Cotinine (Week 12) | 30% Reduction in Urine Cotinine (Week 12) | |
Bupropion HCl | 1 | 1 | 1 | 1 |
Sugar Pill | 2 | 2 | 2 | 2 |
Varenicline | 2 | 2 | 4 | 4 |
Side effects will be monitored by a physician and/or assistant and recorded (SEP). All patients withdrawn from the study because of emerging side effects will be followed until the side effects are resolved. Each item is scored based on a scale of 0=none; 1=mild; 2=moderate; and 3=severe. Below, the data are shown for participants experiencing symptoms on week 12 of the study. (NCT01111149)
Timeframe: Week 12
Intervention | participants (Number) | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Anxiety | Dizziness | Mania | Abnormal Dreams | Abdominal Pain | Headache | Insomnia | Nausea | Psychosis | Dry Mouth | Chest Pain | Irregular Heart Beat | Weakness/Fainting | Diarrhea | Vomiting | Constipation | Confusion | Irritability | Drooling | Cold Sweats | Blurred Vision | Leg Pain/Cramps | |
Bupropion HCl | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 |
Sugar Pill | 3 | 0 | 0 | 3 | 0 | 3 | 1 | 0 | 0 | 2 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
Varenicline | 3 | 0 | 0 | 1 | 1 | 3 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 1 |
Measured by blood/urine tests for nicotine and its break-down product cotinine. (NCT01111149)
Timeframe: Week 12
Intervention | ng/mL (Mean) | |||
---|---|---|---|---|
Serum Cotinine (Week 12) | Serum Nicotine (Week 12) | Urine Cotinine (Week 12) | Urine Nicotine (Week 12) | |
Bupropion HCl | 213.8 | 15.4 | 614.75 | 412.75 |
Sugar Pill | 198.67 | 22.57 | 772 | 820 |
Varenicline | 207 | 6 | 699.6 | 613.25 |
The Columbia-Suicide Severity Rating Scale (C-SSRS), is a survey intended to quantify the severity of suicidal ideation and behavior. The questionaire for suicidal ideation consists of 5 questions with yes (1) /no (0) answers. If answers to questions 1 and 2 are no, questions 3-5 are skipped. Minimum of 0; Maximum of 5. The questionaire for suicidal behavior consists of seven questions rated 0 for no and 1 for yes. The minimum score is 0 and the maximum score is 7. In each case, the higher the score, the greater the severity. (NCT01111149)
Timeframe: Week 12
Intervention | units on a scale (Mean) | |
---|---|---|
Lifetime Suicidal Ideation (week 12) | Lifetime Suicide Attempts (week 12) | |
Bupropion HCl | 0.4 | 0.4 |
Sugar Pill | 1.71 | 1.29 |
Varenicline | 0.8 | 1.2 |
The Minnesota Nicotine Withdrawal Scale (MNWS) includes two items where individuals are asked to 1) declare the percentage of time they had an urge to smoke (MNWS % Urge to Smoke); and 2) declare the percentage of time they had a strong urge to smoke (MNWS % Strong Urge). For each case, percentages range from 0% to 100% - the higher the percentage, the greater urge to smoke. (NCT01111149)
Timeframe: Week 12
Intervention | percentage of time (Mean) | |
---|---|---|
MNWS % Urge to Smoke (Week 12) | MNWS % Strong Urge (Week 12) | |
Bupropion HCl | 47 | 32.4 |
Sugar Pill | 36.43 | 26.43 |
Varenicline | 47 | 33 |
blood pressure will be measured. (NCT01111149)
Timeframe: Week 12
Intervention | mm Hg (Mean) | |
---|---|---|
Systolic Blood Pressure (Week 12) | Diastolic Blood Pressure (Week 12) | |
Bupropion HCl | 128.4 | 74.8 |
Sugar Pill | 116.29 | 76.71 |
Varenicline | 122 | 78.4 |
1 review available for bupropion and Psychoses
Article | Year |
---|---|
Psychopharmacotherapy of psychiatric syndromes in asymptomatic and symptomatic HIV infection.
Topics: Acquired Immunodeficiency Syndrome; Adult; Antidepressive Agents; Anxiety Disorders; Bupropion; Depr | 1991 |
4 trials available for bupropion and Psychoses
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 |
Antismoking and potential antipsychotic effects of varenicline in subjects with schizophrenia or schizoaffective disorder: a double-blind placebo and bupropion-controlled study.
Topics: Antidepressive Agents, Second-Generation; Antipsychotic Agents; Benzazepines; Bupropion; Double-Blin | 2013 |
Comparison of bupropion alone and with haloperidol in schizo-affective disorder, depressed type.
Topics: Adolescent; Adult; Bupropion; Depressive Disorder; Drug Therapy, Combination; Female; Haloperidol; H | 1983 |
Bupropion in the long-term treatment of cyclic mood disorders: mood stabilizing effects.
Topics: Adult; Antidepressive Agents; Antipsychotic Agents; Bipolar Disorder; Body Weight; Bupropion; Chroni | 1985 |
8 other studies available for bupropion and Psychoses
Article | Year |
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Therapies for obesity and medication-associated weight gain.
Topics: Animals; Appetite Depressants; Bariatric Surgery; Benzazepines; Bupropion; Chronic Disease; Combined | 2013 |
Two acute psychotic episodes after administration of bupropion: a case of involuntary rechallenge.
Topics: Adult; Antidepressive Agents, Second-Generation; Bupropion; Delirium; Diagnosis, Dual (Psychiatry); | 2009 |
Use of antidepressants during pregnancy and risk of attention-deficit/hyperactivity disorder in the offspring.
Topics: Adult; Antidepressive Agents, Second-Generation; Attention Deficit Disorder with Hyperactivity; Bipo | 2010 |
QTc prolongation in multiple drug overdose.
Topics: Adult; Bupropion; Drug Overdose; Fluoxetine; Humans; Long QT Syndrome; Male; Piperazines; Psychotic | 2004 |
[Acute psychosis after administration of bupropion hydrochloride (Zyban)].
Topics: Acute Disease; Antidepressive Agents, Second-Generation; Bupropion; Delayed-Action Preparations; Hum | 2004 |
Schizo-affective disorder: diagnostic criteria.
Topics: Bupropion; Depressive Disorder; Humans; Manuals as Topic; Propiophenones; Psychotic Disorders | 1984 |
Antidepressant-associated mania: a controlled comparison with spontaneous mania.
Topics: Adult; Akathisia, Drug-Induced; Antidepressive Agents; Antidepressive Agents, Tricyclic; Bipolar Dis | 1994 |
Serum sickness induced by bupropion.
Topics: Antidepressive Agents, Second-Generation; Bupropion; Depression; Female; Humans; Middle Aged; Psycho | 1999 |