fluconazole has been researched along with Serotonin Syndrome in 2 studies
Fluconazole: Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.
fluconazole : A member of the class of triazoles that is propan-2-ol substituted at position 1 and 3 by 1H-1,2,4-triazol-1-yl groups and at position 2 by a 2,4-difluorophenyl group. It is an antifungal drug used for the treatment of mucosal candidiasis and for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis.
Serotonin Syndrome: An adverse drug interaction characterized by altered mental status, autonomic dysfunction, and neuromuscular abnormalities. It is most frequently caused by use of both serotonin reuptake inhibitors and monoamine oxidase inhibitors, leading to excess serotonin availability in the CNS at the serotonin 1A receptor.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Sertraline was associated with excess SAEs of psychosis." | 2.94 | Adjunctive sertraline for asymptomatic cryptococcal antigenemia: A randomized clinical trial. ( Bangdiwala, AS; Boulware, DR; Hullsiek, KH; Kirumira, P; Meya, DB; Nalintya, E; Naluyima, R; Namanda, S; Nikweri, Y; Rajasingham, R; Rutakingirwa, MK; Skipper, CP; Turya, F, 2020) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 1 (50.00) | 29.6817 |
| 2010's | 0 (0.00) | 24.3611 |
| 2020's | 1 (50.00) | 2.80 |
| Authors | Studies |
|---|---|
| Boulware, DR | 1 |
| Nalintya, E | 1 |
| Rajasingham, R | 1 |
| Kirumira, P | 1 |
| Naluyima, R | 1 |
| Turya, F | 1 |
| Namanda, S | 1 |
| Rutakingirwa, MK | 1 |
| Skipper, CP | 1 |
| Nikweri, Y | 1 |
| Hullsiek, KH | 1 |
| Bangdiwala, AS | 1 |
| Meya, DB | 1 |
| Dougherty, JA | 1 |
| Young, H | 1 |
| Shafi, T | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Cryptococcal Antigen Screening Plus Sertraline[NCT03002012] | Phase 3 | 22 participants (Actual) | Interventional | 2017-11-15 | Terminated (stopped due to SAEs with n=1 serotonin syndrome, n=2 SAEs after sertraline interruption.) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"Cryptococcal meningitis free survival with retention-in-care through 6 months~Those who die of any cause are failures~Those developing symptomatic cryptococcal meningitis are failures~Those lost to follow up and unable to be tracked are considered failures" (NCT03002012)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Sertraline | 11 |
| Control | 9 |
Survival through 6 months (NCT03002012)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Sertraline | 11 |
| Control | 10 |
Number of participants whose study drug/placebo use was halted prematurely due to any cause through 6 months (NCT03002012)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Sertraline | 1 |
| Control | 0 |
Cumulative incidence of symptomatic cryptococcal meningoencephalitis through 6 months (NCT03002012)
Timeframe: 6 months
| Intervention | meningitis events (Number) |
|---|---|
| Sertraline | 0 |
| Control | 1 |
Number of Clinical Adverse Events by Division of AIDS (DAIDS) Scale for Grade 3-5 events through 6 months (NCT03002012)
Timeframe: 6 months
| Intervention | number of grade 3-5 adverse events (Number) |
|---|---|
| Sertraline | 4 |
| Control | 2 |
Number of Laboratory Grade 3-5 Adverse Events through 6 months as per the Division of AIDS (DAIDS) grading scale (NCT03002012)
Timeframe: 6 months
| Intervention | number of grade 3-5 adverse events (Number) |
|---|---|
| Sertraline | 4 |
| Control | 1 |
Participants' percent adherence to study drug regiment by pharmacy medication counts, representing the percent of the total prescribed medication taken by participants. (NCT03002012)
Timeframe: 12 weeks
| Intervention | Percent of total prescribed medication t (Median) | |||
|---|---|---|---|---|
| Week 2 | Week 4 | Week 8 | Week 12 | |
| Control | 100 | 100 | 100 | 100 |
| Sertraline | 100 | 100 | 97 | 89 |
Prevalence of depression by Patient Health Questionnaire (PHQ-9) over 6 months as measured at baseline, 4 weeks, 8 weeks, and 12 weeks. The PHQ-9 is a 9-item instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Items are rated on a scale from 0 (not at all) to 3 (nearly every day). Total score is a sum of 9 item scores (Range 0-27). Greater scores indicate greater depressive symptoms. PHQ-9 scores of: 0-4 Minimal/No depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderate severe depression; 20-27 Severe depression. This endpoint reports the median (interquartile range) of the PHQ-9 scores over time. (NCT03002012)
Timeframe: 12 weeks
| Intervention | score on a scale (Median) | ||
|---|---|---|---|
| Week 4 | Week 8 | Week 12 | |
| Control | 5 | 3 | 2 |
| Sertraline | 5 | 6 | 2 |
1 trial available for fluconazole and Serotonin Syndrome
| Article | Year |
|---|---|
Adjunctive sertraline for asymptomatic cryptococcal antigenemia: A randomized clinical trial.
Topics: Adult; AIDS-Related Opportunistic Infections; Antifungal Agents; Antigens, Fungal; Asymptomatic Infe | 2020 |
1 other study available for fluconazole and Serotonin Syndrome
| Article | Year |
|---|---|
Serotonin syndrome induced by amitriptyline, meperidine, and venlafaxine.
Topics: Adult; Amitriptyline; Analgesics; Antifungal Agents; Cyclohexanols; Drug Interactions; Female; Fluco | 2002 |