Study Underlying disorder (N) Methods Outcome Concomitant medication
Ahmed et al. [74] Bipolar disorder (1) Case report;  Duration: 7 days (1mg/day) Acute manic episode   mianserin (90 mg/day), oxazepam (10 mg/day), acetylsalicylic acid (80 mg/day), barnidipine (20 mg/day), hydrochlorothiazide (12.5 mg/day), perindopril (8 mg/day) and rosuvastatin (5 mg/day)
Francois et al. [75] None (1) Case report;  Duration: 7 days (dose not specified) Grandiose delusions, agitation, insomnia, rapid speech None
Freedman,  [76] Schizophrenia (1) Case report;  Duration: 5 days (1 mg BID) Exacerbation of psychotic symptoms Thiothixene (1015mg/day)
Hussain et al. [77] History of mild depression (1) Case report;  Duration: approximately three weeks (0.5mg/day) Manic episode Oxycodone (up to 12 pills/day), diazepam (10mg/day)
Ismail et al. [78] Schizophrenia (1) Case report;  Duration: 20 days (1 mg BID) Significant reduced smoking and self report craving to smoke. Polydipsia and hyponatremia Depot risperidone (25mg /2 weeks)
Kohen and Kremen,  [79] Bipolar disorder (1) Case report;  Duration: 7 days (2mg/day) Exacerbation of manic episode valproic acid (dose not specified)
Morstad, [81] Bipolar II disorder, polysubstance abuse (1) Case report;  Duration: approximately one month (2mg/day) Hypomanic episode with suicidal ideation bupropion XL (300 mg/day), clonazepam (1 mg/day), oxcarbazepine (450 mg/day), quetiapine (100 mg/day), montelukast (10 mg/day), pantoprazole (40 mg/day)
Popkin, [82] Major depression Case report;  Duration: 6 weeks (2mg/day) Hypersomnia, unusual dreams, decreased appetite, irritability, sadness and guilt Fluoxetine (20mg/day), asprin, niacin and metoprolol
Waldo et al. [83] Schizophrenia (6) Pilot study; Duration: 2 hours (1 mg, once) Varenicline did not improve P50 gating. Study discontinued due to emergence of suicidal ideation, aggressive, erratic behavior Atypical APDs
Anghelescu, [86] Schizophrenia (1) Case report;  Duration: 2  weeks (1 mg BID) Complete abstinence confirmed with expired CO level, improvement of negative symptoms 45 to 22 via PANSS Depot risperidone (37.5mg/2 weeks)
Fatemi, [87] Schizophrenia (1) Case report;  Duration: >24 weeks (1 mg BID) Meaningful reduction in number of cigarettes smoked Clozapine (700mg/day) and citalopram (40 mg/day)
Evins and Goff, [88] Schizophrenia (16) Case series;  Duration: 12 weeks (1 mg BID) Reduced craving to smoke, 13 patients quit smoking (expired CO level <9 ppm), self report abstinence ≥12 weeks Various antipsychotics
Smith et al. [90] Schizophrenia (9);                Schizoaffective (3) Case series;  Duration: 9 weeks (1 mg BID) Significant decrease in plasma cotinine (p <0.01), expired CO level (p<0.05), self reported smoking urges, number of cigarettes smoked and nicotine level. Improvement in some cognitive test  score Various antipsychotics
Weiner et al. [91] Schizophrenia (8) Double blind randomized trial;  Duration: 12 weeks (1 mg BID) Sustained abstinent and significant reduction in CO level <10 ppm (p=0.02)in Varenicline group Atypical antipsychotics
Dutra et al. [93] Schizophrenia or Schizoaffective disorder (53) Trial combined with CBT; Duration: 12 weeks (1 mg BID) 60.4% attained abstinence, significantly reduced CO levels (p<0.001) compared with baseline Various antipsychotics
Pirmoradi et al. [100] Alcohol abuse and MDD (1) Case report;  Duration: 7 days (1mg/day) Experience of severe anxiety  eszopiclone (2 mg/day), fluoxetine (20 mg/day), bupropion hydrochloride (300 mg/day), lisinopril (10 mg/day) and hydrochlorothiazide 12.5 mg/day) 
Pumariega et al.  [101] MDD (1) Case report;  Duration: 90 days (dose not specified) Creation of manic episode Sertraline (dose not specified)
DiPaula and Thomas, [102] Bipolar disorder (1) Case report;  Duration: 2 days (2mg/day) Exacerbation of psychotic symptoms and agitation Hallopridol, olanzapine, lorazpam and diphenhydramine (dose not specified)
Liu et al.          [103] Schizoaffective disorder (1) Case report;  Duration: 13 days (dose not specified) Exacerbation of mania episode with psychotic features clothiapine (160 mg/day) and lithium (1,200 mg/day)
Lyon, [104] MDD, GAD, BLPD and marijuana use (1) Case report;  Duration: One month (2mg/day) Paranoia and irritability Topiramate (200 mg/day), duloxetine (120 mg/day), modafinil (400 mg/day) and clonazepam (2mg/day)
Alhatem et al. [105] Bipolar and Adult ADHD disorder (1) Case report;  Duration: 2 weeks (dose not specified) Exacerbation of mania Quetiapine and amphetamine salts (dose not specified)
Kutscher et al. [106] None (1) Case report;  Duration: 10 weeks (dose not specified) Paranoia, anxiety and suicidal ideation Oral contraceptive
Raidoo et al. [107] PTSD, depression, alcohol dependence (1) Case report;  Duration: 19 days (2mg/day) Visual hallucination fluoxetine (20 mg/day), nortriptyline (25 mg/day), quetiapine (50 mg/day), prazosin (1 mg/day), pramipexole (0.5 mg/day), terazosin (5 mg/day), atenolol (50 mg/day) and spironolactone (50 mg/day)
Cinemre et al. [108] Brief episode of atypical psychosis (1) Case report;  Duration: 30 days (dose not specified) Creation of psychotic symptoms None
ADHD: Attention deficit hyperactivity disorder; BLPD: Borderline personality disorder; GAD: Generalized anxiety disorder; MDD, Major depressive disorder;   PTSD, post-traumatic stress disorder
Table 2: Psychiatric side effects of varenicline.
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