fluoxetine has been researched along with Suicidal Ideation in 24 studies
Fluoxetine: The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.
fluoxetine : A racemate comprising equimolar amounts of (R)- and (S)-fluoxetine. A selective serotonin reuptake inhibitor (SSRI), it is used (generally as the hydrochloride salt) for the treatment of depression (and the depressive phase of bipolar disorder), bullimia nervosa, and obsessive-compulsive disorder.
N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine : An aromatic ether consisting of 4-trifluoromethylphenol in which the hydrogen of the phenolic hydroxy group is replaced by a 3-(methylamino)-1-phenylpropyl group.
Suicidal Ideation: A risk factor for suicide attempts and completions, it is the most common of all suicidal behavior, but only a minority of ideators engage in overt self-harm.
| Excerpt | Relevance | Reference |
|---|---|---|
| " This is an analysis of the impact of fluoxetine on suicide ideations in outpatients with minor depressive disorder." | 9.17 | Fluoxetine increases suicide ideation less than placebo during treatment of adults with minor depressive disorder. ( Frank, E; Garlow, SJ; Judd, LL; Kinkead, B; Kupfer, DJ; Rapaport, MH; Rush, AJ; Schettler, PJ; Thase, ME; Yonkers, KA, 2013) |
| "Effective treatment of depression is a key target for suicide prevention strategies." | 7.01 | Trajectories of change in depression symptoms and suicidal ideation over the course of evidence-based treatment for depression: Secondary analysis of a randomised controlled trial of cognitive behavioural therapy plus fluoxetine in young people. ( Berk, M; Chanen, A; Cotton, S; Davey, CG; Dean, O; Hetrick, S; Madsen, T; McGorry, PD; Witt, K, 2021) |
| "Medication is commonly used to treat youth depression, but whether medication should be added to cognitive behavioural therapy (CBT) as first-line treatment is unclear." | 6.90 | The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): a randomised, double-blind, placebo-controlled, multicentre clinical trial. ( Amminger, GP; Berk, M; Catania, L; Chanen, AM; Cotton, SM; Davey, CG; Dean, OM; Harrison, BJ; Hetrick, SE; Kazantzis, N; Kerr, M; Koutsogiannis, J; McGorry, PD; Mullen, E; Parker, AG; Phelan, M; Quinn, AL; Ratheesh, A; Rice, S; Weller, A, 2019) |
| " This is an analysis of the impact of fluoxetine on suicide ideations in outpatients with minor depressive disorder." | 5.17 | Fluoxetine increases suicide ideation less than placebo during treatment of adults with minor depressive disorder. ( Frank, E; Garlow, SJ; Judd, LL; Kinkead, B; Kupfer, DJ; Rapaport, MH; Rush, AJ; Schettler, PJ; Thase, ME; Yonkers, KA, 2013) |
| "Electroconvulsive therapy was superior to fluoxetine in resolving suicidal ideation during acute treatment." | 3.96 | Electroconvulsive Therapy Versus Fluoxetine in Suicidal Resolution for Patients With Major Depressive Disorder. ( Chen, CC; Huang, CJ; Lin, CH, 2020) |
| "Treatment with fluoxetine for 26 weeks did not change the prevalence of these thoughts compared with placebo." | 3.11 | Wishing to die or self-harm after stroke: A planned secondary analysis of the AFFINITY Randomised Controlled Trial. ( Almeida, OP; Etherton-Beer, C; Flicker, L; Ford, A; Hackett, M; Hankey, GJ, 2022) |
| "Effective treatment of depression is a key target for suicide prevention strategies." | 3.01 | Trajectories of change in depression symptoms and suicidal ideation over the course of evidence-based treatment for depression: Secondary analysis of a randomised controlled trial of cognitive behavioural therapy plus fluoxetine in young people. ( Berk, M; Chanen, A; Cotton, S; Davey, CG; Dean, O; Hetrick, S; Madsen, T; McGorry, PD; Witt, K, 2021) |
| "Medication is commonly used to treat youth depression, but whether medication should be added to cognitive behavioural therapy (CBT) as first-line treatment is unclear." | 2.90 | The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): a randomised, double-blind, placebo-controlled, multicentre clinical trial. ( Amminger, GP; Berk, M; Catania, L; Chanen, AM; Cotton, SM; Davey, CG; Dean, OM; Harrison, BJ; Hetrick, SE; Kazantzis, N; Kerr, M; Koutsogiannis, J; McGorry, PD; Mullen, E; Parker, AG; Phelan, M; Quinn, AL; Ratheesh, A; Rice, S; Weller, A, 2019) |
| " Safety measures included treatment-emergent adverse events (TEAEs), the Columbia-Suicide Severity Rating Scale, vital signs, electrocardiograms, laboratory samples, and growth (height and weight) assessments." | 2.80 | Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder. ( Bangs, ME; Emslie, GJ; March, JS; Pangallo, BA; Prakash, A; Wells, TG; Zhang, Q, 2015) |
| " Measures included: Children's Depression Rating Scale-Revised (CDRS-R), treatment-emergent adverse events (TEAEs), and Columbia-Suicide Severity Rating Scale (C-SSRS)." | 2.79 | A double-blind efficacy and safety study of duloxetine flexible dosing in children and adolescents with major depressive disorder. ( Atkinson, SD; Bangs, ME; Emslie, GJ; March, JS; Pangallo, BA; Prakash, A; Zhang, Q, 2014) |
| " Measures included: Children's Depression Rating Scale-Revised (CDRS-R), treatment-emergent adverse events (TEAEs), and Columbia-Suicide Severity Rating Scale (C-SSRS)." | 2.79 | A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder. ( Bangs, ME; Emslie, GJ; March, JS; Pangallo, BA; Prakash, A; Zhang, Q, 2014) |
| "There are limited data on the impact of insomnia in response to acute treatment, which is particularly relevant with serotonin-selective reuptake inhibitors, given their tendency to worsen sleep architecture." | 2.77 | Insomnia moderates outcome of serotonin-selective reuptake inhibitor treatment in depressed youth. ( Croarkin, P; Emslie, GJ; Hughes, C; Kennard, BD; Mayes, TL; Nakonezny, PA; Tao, R; Zhu, L, 2012) |
| "A link between insomnia and suicide has not been previously examined in the setting of a clinical trial." | 2.75 | Insomnia severity is an indicator of suicidal ideation during a depression clinical trial. ( Blocker, JN; Boggs, N; D'Agostino, R; Kimball, J; Lasater, B; McCall, WV; Rosenquist, PB, 2010) |
| "Major depressive disorders have a significant impact on children and adolescents, including on educational and vocational outcomes, interpersonal relationships, and physical and mental health and well-being." | 2.72 | New generation antidepressants for depression in children and adolescents: a network meta-analysis. ( Badcock, PB; Bailey, AP; Cox, GR; Hetrick, SE; McKenzie, JE; Meader, N; Merry, SN; Moller, CI; Sharma, V, 2021) |
| "Depression is one of the leading causes of disability in developing countries including Pakistan." | 1.46 | Depressive symptoms, monoamines levels, MAO-B activity and effect of treatment in a subset of depressed individuals from government sector hospital at Karachi. ( Farooq, AD; Naqvi, S; Rahman, R; Zeb, F, 2017) |
| " On the basis of these data, novel dosing strategies were developed for five antidepressants to mimic the pharmacological profile of the antidepressant with the longest half-life, fluoxetine." | 1.42 | The role of 5-HT1A receptors in mediating acute negative effects of antidepressants: implications in pediatric depression. ( Cao, YJ; Hendrix, CW; Kaplin, AI; Rahn, KA, 2015) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 15 (62.50) | 24.3611 |
| 2020's | 9 (37.50) | 2.80 |
| Authors | Studies |
|---|---|
| Almeida, OP | 1 |
| Hankey, GJ | 1 |
| Ford, A | 1 |
| Etherton-Beer, C | 1 |
| Flicker, L | 1 |
| Hackett, M | 1 |
| Kwon, CY | 1 |
| Lee, B | 1 |
| Amitai, M | 2 |
| Taler, M | 2 |
| Ben-Baruch, R | 2 |
| Lebow, M | 2 |
| Rotkopf, R | 1 |
| Apter, A | 2 |
| Fennig, S | 2 |
| Weizman, A | 2 |
| Chen, A | 2 |
| Lin, CH | 1 |
| Chen, CC | 1 |
| Huang, CJ | 1 |
| Christodoulos, IN | 1 |
| Chyou, TY | 1 |
| Nishtala, PS | 1 |
| Taylor, R | 1 |
| Bodoukhin, N | 1 |
| Botros, M | 1 |
| Luca, L | 1 |
| Witt, K | 1 |
| Madsen, T | 1 |
| Berk, M | 2 |
| Dean, O | 1 |
| Chanen, A | 1 |
| McGorry, PD | 2 |
| Cotton, S | 1 |
| Davey, CG | 2 |
| Hetrick, S | 1 |
| Hetrick, SE | 2 |
| McKenzie, JE | 1 |
| Bailey, AP | 1 |
| Sharma, V | 1 |
| Moller, CI | 1 |
| Badcock, PB | 1 |
| Cox, GR | 1 |
| Merry, SN | 1 |
| Meader, N | 1 |
| Zeb, F | 1 |
| Naqvi, S | 1 |
| Rahman, R | 1 |
| Farooq, AD | 1 |
| Lewis, CP | 1 |
| Camsari, DD | 1 |
| Sonmez, AI | 1 |
| Nandakumar, AL | 1 |
| Gresbrink, MA | 1 |
| Daskalakis, ZJ | 1 |
| Croarkin, PE | 1 |
| Chanen, AM | 1 |
| Cotton, SM | 1 |
| Ratheesh, A | 1 |
| Amminger, GP | 1 |
| Koutsogiannis, J | 1 |
| Phelan, M | 1 |
| Mullen, E | 1 |
| Harrison, BJ | 1 |
| Rice, S | 1 |
| Parker, AG | 1 |
| Dean, OM | 1 |
| Weller, A | 1 |
| Kerr, M | 1 |
| Quinn, AL | 1 |
| Catania, L | 1 |
| Kazantzis, N | 1 |
| Garlow, SJ | 2 |
| Kinkead, B | 1 |
| Thase, ME | 1 |
| Judd, LL | 1 |
| Rush, AJ | 1 |
| Yonkers, KA | 1 |
| Kupfer, DJ | 1 |
| Frank, E | 1 |
| Schettler, PJ | 1 |
| Rapaport, MH | 1 |
| Stone, MB | 1 |
| Hammad, TA | 1 |
| Atkinson, SD | 1 |
| Prakash, A | 3 |
| Zhang, Q | 3 |
| Pangallo, BA | 3 |
| Bangs, ME | 3 |
| Emslie, GJ | 4 |
| March, JS | 3 |
| Rahn, KA | 1 |
| Cao, YJ | 1 |
| Hendrix, CW | 1 |
| Kaplin, AI | 1 |
| Wells, TG | 1 |
| McCall, WV | 1 |
| Blocker, JN | 1 |
| D'Agostino, R | 1 |
| Kimball, J | 1 |
| Boggs, N | 1 |
| Lasater, B | 1 |
| Rosenquist, PB | 1 |
| Goldsmith, L | 1 |
| Moncrieff, J | 1 |
| Taurines, R | 1 |
| Gerlach, M | 1 |
| Warnke, A | 1 |
| Thome, J | 1 |
| Wewetzer, C | 1 |
| Kennard, BD | 1 |
| Mayes, TL | 1 |
| Nakonezny, PA | 1 |
| Zhu, L | 1 |
| Tao, R | 1 |
| Hughes, C | 1 |
| Croarkin, P | 1 |
| Devi, S | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) a Multicentre Open-label Randomized Controlled Trial Protocol[NCT05814640] | Phase 1/Phase 2 | 520 participants (Anticipated) | Interventional | 2023-02-20 | Recruiting | ||
| A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder[NCT04502758] | 80 participants (Anticipated) | Interventional | 2022-04-04 | Recruiting | |||
| A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder[NCT00849901] | Phase 3 | 337 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
| A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder[NCT00849693] | Phase 3 | 463 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
| Hypnotics in the Treatment of Psychiatric Disorders[NCT00247624] | Phase 4 | 60 participants (Actual) | Interventional | 2005-10-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Baseline, Week 10
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine | -24.3 |
| Fluoxetine | -23.7 |
| Placebo | -24.3 |
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Baseline, Week 10
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine | -1.9 |
| Fluoxetine | -1.8 |
| Placebo | -1.9 |
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Week 10, Week 36
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine/Duloxetine | -7.2 |
| Fluoxetine/Fluoxetine | -9.9 |
| Placebo/Duloxetine | -9.6 |
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Week 10, Week 36
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine/Duloxetine | -0.6 |
| Fluoxetine/Fluoxetine | -1.0 |
| Placebo/Duloxetine | -1.1 |
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Baseline, Week 10
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Mood (N=113, 113, 103) | Somatic (N=113, 113, 103) | Subjective (N=113, 113, 103) | Behavior (N=113, 112, 103) | |
| Duloxetine | -7.0 | -7.7 | -4.0 | -5.6 |
| Fluoxetine | -7.1 | -7.6 | -3.6 | -5.4 |
| Placebo | -7.0 | -7.7 | -4.0 | -5.7 |
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849901)
Timeframe: Week 10, Week 36
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Mood | Somatic | Subjective | Behavior | |
| Duloxetine/Duloxetine | -1.9 | -2.8 | -0.3 | -1.9 |
| Fluoxetine/Fluoxetine | -2.5 | -3.6 | -1.3 | -2.8 |
| Placebo/Duloxetine | -2.9 | -3.2 | -1.2 | -2.1 |
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN. (NCT00849901)
Timeframe: Baseline through Week 10
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| ALT≥3 x ULN | ALT≥5 x ULN | ALT≥10 x ULN | ALT≥3 x ULN and Total Bilirubin≥2 x ULN | |
| Duloxetine | 0 | 0 | 0 | 0 |
| Fluoxetine | 0 | 0 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 |
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN. (NCT00849901)
Timeframe: Week 10 through Week 36
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| ALT≥3 x ULN | ALT≥5 x ULN | ALT≥10 x ULN | ALT≥3 x ULN and Total Bilirubin≥2 x ULN | |
| Duloxetine/Duloxetine | 0 | 0 | 0 | 0 |
| Fluoxetine/Fluoxetine | 1 | 1 | 0 | 0 |
| Placebo/Duloxetine | 0 | 0 | 0 | 0 |
"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 - 0)." (NCT00849901)
Timeframe: Baseline through Week 10
| Intervention | participants (Number) | ||
|---|---|---|---|
| Suicidal Ideation | Suicidal Behavior | Treatment Emergent Suicidal Ideation | |
| Duloxetine | 16 | 0 | 8 |
| Fluoxetine | 16 | 1 | 9 |
| Placebo | 15 | 0 | 7 |
"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)." (NCT00849901)
Timeframe: Week 10 through Week 36
| Intervention | participants (Number) | ||
|---|---|---|---|
| Suicidal Ideation | Suicidal Behavior | Treatment Emergent Suicidal Ideation | |
| Duloxetine/Duloxetine | 13 | 1 | 9 |
| Fluoxetine/Fluoxetine | 13 | 1 | 13 |
| Placebo/Duloxetine | 8 | 0 | 8 |
PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value. (NCT00849901)
Timeframe: Baseline through Week 10
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Diastolic BP Increase (N=102, 106, 93) | Systolic BP Increase (N=100, 106, 90) | Pulse Decrease (N=111, 112, 102) | Pulse Increase (N=113, 114, 103) | Weight Decrease (N=113, 114, 103) | |
| Duloxetine | 8.8 | 7.0 | 0.9 | 0 | 12.4 |
| Fluoxetine | 7.5 | 5.7 | 0.9 | 0 | 11.4 |
| Placebo | 17.2 | 6.7 | 1.0 | 1.0 | 4.9 |
PCS increase in systolic and diastolic BP was defined as increase of ≥ 5mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value. (NCT00849901)
Timeframe: Week 10 through Week 36
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Diastolic BP Increase (N=65, 76, 61) | Systolic BP Increase (N=64, 80, 69) | Pulse Decrease (N=78, 84, 82) | Pulse Increase (N=81, 91, 84) | Weight Decrease (N=81, 91, 85) | |
| Duloxetine/Duloxetine | 16.9 | 12.5 | 0 | 0 | 6.2 |
| Fluoxetine/Fluoxetine | 11.8 | 12.5 | 0 | 0 | 3.3 |
| Placebo/Duloxetine | 4.9 | 10.1 | 0 | 0 | 9.4 |
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Baseline, Week 10
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine 60mg | -23.9 |
| Placebo | -21.6 |
| Duloxetine 30mg | -24.6 |
| Fluoxetine 20mg | -22.6 |
| Placebo | -21.6 |
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Baseline, Week 10
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine 60mg | -1.5 |
| Duloxetine 30mg | -1.5 |
| Fluoxetine 20mg | -1.4 |
| Placebo | -1.4 |
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Week 10, Week 36
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine 60 mg / Duloxetine 60-120 mg | -7.8 |
| Duloxetine 30 mg/Duloxetine 60-120 mg | -7.4 |
| Fluoxetine 20 mg/Fluoxetine 20-40 mg | -10.0 |
| Placebo/Duloxetine 60-120 mg | -9.0 |
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Week 10, Week 36
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine 60 mg / Duloxetine 60-120 mg | -1.1 |
| Duloxetine 30 mg/Duloxetine 60-120 mg | -0.9 |
| Fluoxetine 20 mg/Fluoxetine 20-40 mg | -1.3 |
| Placebo/Duloxetine 60-120 mg | -1.0 |
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Baseline, Week 10
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Mood | Somatic | Subjective | Behavior | |
| Duloxetine 30mg | -7.2 | -7.9 | -4.0 | -5.6 |
| Duloxetine 60mg | -7.1 | -7.6 | -3.6 | -5.8 |
| Fluoxetine 20mg | -6.6 | -7.1 | -3.5 | -5.6 |
| Placebo | -6.4 | -6.4 | -3.6 | -5.4 |
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. (NCT00849693)
Timeframe: Week 10, Week 36
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Mood | Somatic | Subjective | Behavior | |
| Duloxetine 30 mg/Duloxetine 60-120 mg | -1.9 | -2.4 | -1.3 | -1.8 |
| Duloxetine 60 mg / Duloxetine 60-120 mg | -1.9 | -2.8 | -1.2 | -2.1 |
| Fluoxetine 20 mg/Fluoxetine 20-40 mg | -2.4 | -4.0 | -1.5 | -2.7 |
| Placebo/Duloxetine 60-120 mg | -2.3 | -3.2 | -1.0 | -2.4 |
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN. (NCT00849693)
Timeframe: Baseline through Week 10
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| ALT≥3 x ULN | ALT≥5 x ULN | ALT≥10 x ULN | ALT≥3 x ULN and Total Bilirubin≥2 x ULN | |
| Duloxetine 30mg | 0 | 0 | 0 | 0 |
| Duloxetine 60mg | 0 | 0 | 0 | 0 |
| Fluoxetine 20mg | 0 | 0 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 |
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN. (NCT00849693)
Timeframe: Week 10 through Week 36
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| ALT≥3 x ULN | ALT≥5 x ULN | ALT≥10 x ULN | ALT≥3 x ULN and Total Bilirubin≥2 x ULN | |
| Duloxetine 30 mg/Duloxetine 60-120 mg | 0 | 0 | 0 | 0 |
| Duloxetine 60 mg / Duloxetine 60-120 mg | 0 | 0 | 0 | 0 |
| Fluoxetine 20 mg/Fluoxetine 20-40 mg | 0 | 0 | 0 | 0 |
| Placebo/Duloxetine 60-120 mg | 0 | 0 | 0 | 0 |
"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0)." (NCT00849693)
Timeframe: Baseline through Week 10
| Intervention | participants (Number) | ||
|---|---|---|---|
| Suicidal Ideation | Suicidal Behavior | Treatment Emergent Suicidal Ideation | |
| Duloxetine 30mg | 11 | 0 | 6 |
| Duloxetine 60mg | 16 | 0 | 7 |
| Fluoxetine 20mg | 13 | 1 | 9 |
| Placebo | 15 | 1 | 11 |
"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)." (NCT00849693)
Timeframe: Week 10 through Week 36
| Intervention | participants (Number) | ||
|---|---|---|---|
| Suicidal Ideation | Suicidal Behavior | Treatment Emergent Suicidal Ideation | |
| Duloxetine 30 mg/Duloxetine 60-120 mg | 12 | 3 | 8 |
| Duloxetine 60 mg / Duloxetine 60-120 mg | 6 | 2 | 5 |
| Fluoxetine 20 mg/Fluoxetine 20-40 mg | 8 | 0 | 7 |
| Placebo/Duloxetine 60-120 mg | 8 | 1 | 6 |
PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value. (NCT00849693)
Timeframe: Baseline through Week 10
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Diastolic BP Increase (N=93, 100, 99, 110) | Systolic BP Increase (N=88, 95, 93, 98) | Pulse Decrease (N=100, 108, 108, 112) | Pulse Increase (N=105, 114, 112, 117) | Weight Decrease (N=105, 114, 112, 117) | |
| Duloxetine 30mg | 7.0 | 12.6 | 0 | 0 | 8.8 |
| Duloxetine 60mg | 11.8 | 9.1 | 0 | 0 | 13.3 |
| Fluoxetine 20mg | 10.1 | 12.9 | 0 | 0 | 11.6 |
| Placebo | 4.5 | 10.2 | 0 | 0 | 5.1 |
PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value. (NCT00849693)
Timeframe: Week 10 through Week 36
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Diastolic BP Increase (N=55, 65, 64, 69) | Systolic BP Increase (N=53, 62, 57, 57) | Pulse Decrease (N=68, 75, 76, 73) | Pulse Increase (N=71, 78, 81, 79) | Weight Decrease (N=71, 78, 81, 79) | |
| Duloxetine 30 mg/Duloxetine 60-120 mg | 4.6 | 6.5 | 0 | 0 | 9.0 |
| Duloxetine 60 mg / Duloxetine 60-120 mg | 14.5 | 9.4 | 0 | 1.4 | 2.8 |
| Fluoxetine 20 mg/Fluoxetine 20-40 mg | 20.3 | 7.0 | 0 | 0 | 3.7 |
| Placebo/Duloxetine 60-120 mg | 11.6 | 10.5 | 0 | 1.3 | 13.9 |
"The BASIS 32 psychometric includes several subscales, including daily living and role functioning (DLRF). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension and lower scores denoting better outcomes. Measured weekly for 9 weeks. Reported as mean of 9 weeks." (NCT00247624)
Timeframe: 9 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Fluoxetine (FLX) Plus Eszopiclone (ESZ) | 0.81 |
| FLX Plus Placebo | 1.2 |
The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score, range 0-28. Lower scores represent better outcomes. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe). (NCT00247624)
Timeframe: 9 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Fluoxetine (FLX) Plus Eszopiclone (ESZ) | 21.1 |
| FLX Plus Placebo | 20.2 |
The Q-LES-Q is scored from 0-100, with higher scores better than lower. Measured weekly for 9 weeks. Reported as mean of 9 weeks. (NCT00247624)
Timeframe: 9 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Fluoxetine (FLX) Plus Eszopiclone (ESZ) | 50.2 |
| FLX Plus Placebo | 46.9 |
"The BASIS 32 psychometric includes several subscales, including relation to self and others (RSO). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension. Measured weekly for 9 weeks. Reported as mean of 9 weeks." (NCT00247624)
Timeframe: 9 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Fluoxetine (FLX) Plus Eszopiclone (ESZ) | 0.74 |
| FLX Plus Placebo | 1.04 |
3 reviews available for fluoxetine and Suicidal Ideation
| Article | Year |
|---|---|
The effectiveness and safety of herbal medicine on suicidal behavior: A PRISMA-compliant systematic review and meta-analysis.
Topics: Antidepressive Agents; Fluoxetine; Humans; Plant Extracts; Suicidal Ideation; Suicide | 2023 |
New generation antidepressants for depression in children and adolescents: a network meta-analysis.
Topics: Adolescent; Antidepressive Agents; Bias; Child; Citalopram; Depressive Disorder, Major; Desvenlafaxi | 2021 |
Pharmacotherapy in depressed children and adolescents.
Topics: Adolescent; Anti-Anxiety Agents; Antidepressive Agents; Anxiety Disorders; Child; Combined Modality | 2011 |
9 trials available for fluoxetine and Suicidal Ideation
| Article | Year |
|---|---|
Wishing to die or self-harm after stroke: A planned secondary analysis of the AFFINITY Randomised Controlled Trial.
Topics: Aged; Australia; Fluoxetine; Humans; Male; New Zealand; Self-Injurious Behavior; Stroke; Suicidal Id | 2022 |
Trajectories of change in depression symptoms and suicidal ideation over the course of evidence-based treatment for depression: Secondary analysis of a randomised controlled trial of cognitive behavioural therapy plus fluoxetine in young people.
Topics: Adolescent; Australia; Cognitive Behavioral Therapy; Depression; Depressive Disorder, Major; Fluoxet | 2021 |
The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): a randomised, double-blind, placebo-controlled, multicentre clinical trial.
Topics: Adolescent; Adult; Anxiety; Australia; Cognitive Behavioral Therapy; Combined Modality Therapy; Como | 2019 |
Fluoxetine increases suicide ideation less than placebo during treatment of adults with minor depressive disorder.
Topics: Adolescent; Adult; Aged; Antidepressive Agents, Second-Generation; Depressive Disorder; Double-Blind | 2013 |
A double-blind efficacy and safety study of duloxetine flexible dosing in children and adolescents with major depressive disorder.
Topics: Adolescent; Antidepressive Agents; Child; Depressive Disorder, Major; Dose-Response Relationship, Dr | 2014 |
A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder.
Topics: Adolescent; Antidepressive Agents; Child; Depressive Disorder, Major; Dose-Response Relationship, Dr | 2014 |
Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder.
Topics: Adolescent; Antidepressive Agents; Child; Depressive Disorder, Major; Double-Blind Method; Duloxetin | 2015 |
Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder.
Topics: Adolescent; Antidepressive Agents; Child; Depressive Disorder, Major; Double-Blind Method; Duloxetin | 2015 |
Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder.
Topics: Adolescent; Antidepressive Agents; Child; Depressive Disorder, Major; Double-Blind Method; Duloxetin | 2015 |
Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder.
Topics: Adolescent; Antidepressive Agents; Child; Depressive Disorder, Major; Double-Blind Method; Duloxetin | 2015 |
Insomnia severity is an indicator of suicidal ideation during a depression clinical trial.
Topics: Adolescent; Adult; Aged; Antidepressive Agents, Second-Generation; Azabicyclo Compounds; Depressive | 2010 |
Insomnia moderates outcome of serotonin-selective reuptake inhibitor treatment in depressed youth.
Topics: Adolescent; Age Factors; Antidepressive Agents, Second-Generation; Child; Depressive Disorder, Major | 2012 |
12 other studies available for fluoxetine and Suicidal Ideation
| Article | Year |
|---|---|
Increased circulatory IL-6 during 8-week fluoxetine treatment is a risk factor for suicidal behaviors in youth.
Topics: Adolescent; Child; Depressive Disorder, Major; Female; Fluoxetine; Humans; Interleukin-6; Male; Risk | 2020 |
Electroconvulsive Therapy Versus Fluoxetine in Suicidal Resolution for Patients With Major Depressive Disorder.
Topics: Antidepressive Agents, Second-Generation; Depressive Disorder, Major; Electroconvulsive Therapy; Fem | 2020 |
Safety of fluoxetine use in children and adolescents: a disproportionality analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Topics: Adolescent; Adverse Drug Reaction Reporting Systems; Antidepressive Agents, Second-Generation; Anxie | 2020 |
An increase in IL-6 levels at 6-month follow-up visit is associated with SSRI-emergent suicidality in high-risk children and adolescents treated with fluoxetine.
Topics: Adolescent; Anxiety Disorders; Child; Depressive Disorder, Major; Female; Fluoxetine; Follow-Up Stud | 2020 |
Joy Journal: A Behavioral Activation Technique Used in the Treatment of Late-Life Depression Associated With Hopelessness During the COVID-19 Pandemic.
Topics: Aged; Antidepressive Agents; Aripiprazole; Cognitive Behavioral Therapy; COVID-19; Depressive Disord | 2021 |
Depressive symptoms, monoamines levels, MAO-B activity and effect of treatment in a subset of depressed individuals from government sector hospital at Karachi.
Topics: Adolescent; Adult; Affect; Aged; Antidepressive Agents, Second-Generation; Biomarkers; Case-Control | 2017 |
Preliminary evidence of an association between increased cortical inhibition and reduced suicidal ideation in adolescents treated for major depression.
Topics: Adolescent; Adolescent Behavior; Antidepressive Agents, Second-Generation; Bupropion; Citalopram; De | 2019 |
Fluoxetine and suicidal ideation in minor depression.
Topics: Antidepressive Agents, Second-Generation; Depressive Disorder; Female; Fluoxetine; Humans; Male; Sui | 2014 |
Response to the letter from Marc B Stone, MD; Tarek A Hammad, MD, PhD, MSc, MS.
Topics: Antidepressive Agents, Second-Generation; Depressive Disorder; Female; Fluoxetine; Humans; Male; Sui | 2014 |
The role of 5-HT1A receptors in mediating acute negative effects of antidepressants: implications in pediatric depression.
Topics: Adrenergic Uptake Inhibitors; Animals; Antidepressive Agents; Anxiety; Behavior, Animal; Child; Depr | 2015 |
The psychoactive effects of antidepressants and their association with suicidality.
Topics: Adolescent; Adult; Aged; Antidepressive Agents, Second-Generation; Cyclohexanols; Emotions; Female; | 2011 |
Antidepressant-suicide link in children questioned.
Topics: Adolescent; Antidepressive Agents; Child; Depression; Depressive Disorder, Major; Drug Prescriptions | 2012 |