fluoxetine has been researched along with Fatigue in 20 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.
Fatigue: The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.
Excerpt | Relevance | Reference |
---|---|---|
"The EFFECTS (Efficacy of Fluoxetine—a Randomised Controlled Trial in Stroke) recently reported that 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia at 6 months." | 9.41 | Effects of Fluoxetine on Outcomes at 12 Months After Acute Stroke: Results From EFFECTS, a Randomized Controlled Trial. ( Borg, J; Dennis, MS; Greilert Norin, N; Hackett, ML; Hankey, GJ; Isaksson, E; Lundström, E; Mårtensson, B; Mead, GE; Näsman, P; Norrving, B; Sunnerhagen, KS; Wallén, H; Wester, P, 2021) |
"The AFFINITY trial (Assessment of Fluoxetine in Stroke Recovery) reported that oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and seizures." | 9.41 | Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke: AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration. ( Almeida, OP; Anderson, CS; Billot, L; Dennis, MS; Etherton-Beer, C; Flicker, L; Ford, AH; Gommans, J; Hackett, ML; Hankey, GJ; Jan, S; Lundström, E; Lung, T; Mead, GE; Sunnerhagen, KS; Thang-Nguyen, H; Yi, Q, 2021) |
" This open-label study evaluated the efficacy and safety of modafinil treatment initiated with an SSRI in patients with MDD and fatigue." | 9.11 | Adjunctive modafinil at initiation of treatment with a selective serotonin reuptake inhibitor enhances the degree and onset of therapeutic effects in patients with major depressive disorder and fatigue. ( Glass, SJ; Hassman, HA; McManus, FC; Ninan, PT, 2004) |
"One hundred twenty-three men with HIV/AIDS with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition depressive disorder entered the 8-week trial and were randomized to testosterone (up to 400 mg IM testosterone cypionate biweekly), fluoxetine (up to 60 mg/d), or double placebo." | 9.11 | Testosterone versus fluoxetine for depression and fatigue in HIV/AIDS: a placebo-controlled trial. ( Lin, SH; McElhiney, MC; Rabkin, JG; Rabkin, R; Wagner, GJ, 2004) |
"To determine whether fluoxetine, at any dose, given within the first year after stroke to patients who did not have to have mood disorders at randomization reduced disability, dependency, neurological deficits and fatigue; improved motor function, mood, and cognition at the end of treatment and follow-up, with the same number or fewer adverse effects." | 9.05 | Fluoxetine for stroke recovery: Meta-analysis of randomized controlled trials. ( Barugh, A; Dennis, MS; Hackett, ML; Hankey, GJ; Hsieh, CF; Kutlubaev, M; Legg, L; Lundström, E; Mead, GE; Rudberg, AS; Soleimani, B; Tilney, R; Wu, S, 2020) |
"Serotonin, a neurotransmitter synthesized from tryptophan, has been proposed to play a key role in central fatigue." | 7.78 | Essential role of excessive tryptophan and its neurometabolites in fatigue. ( Azechi, H; Board, M; Yamamoto, T, 2012) |
"Fatigue is a common symptom in primary biliary cirrhosis (PBC)." | 6.72 | Fluoxetine for the treatment of fatigue in primary biliary cirrhosis: a randomized, double-blind controlled trial. ( Donlinger, JJ; Gossard, AA; Jorgensen, RA; Keach, JC; Lindor, KD; Petz, JC; Talwalkar, JA, 2006) |
"Treatment with fluoxetine had no effect on tumor growth, muscle wasting, fatigue behavior, or cytokine expression in the brain." | 5.42 | Fluoxetine prevents the development of depressive-like behavior in a mouse model of cancer related fatigue. ( Bicer, S; Devine, R; Godbout, JP; Jing, R; McCarthy, DO; Norden, DM; Reiser, PJ; Wold, LE, 2015) |
"The EFFECTS (Efficacy of Fluoxetine—a Randomised Controlled Trial in Stroke) recently reported that 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia at 6 months." | 5.41 | Effects of Fluoxetine on Outcomes at 12 Months After Acute Stroke: Results From EFFECTS, a Randomized Controlled Trial. ( Borg, J; Dennis, MS; Greilert Norin, N; Hackett, ML; Hankey, GJ; Isaksson, E; Lundström, E; Mårtensson, B; Mead, GE; Näsman, P; Norrving, B; Sunnerhagen, KS; Wallén, H; Wester, P, 2021) |
"The AFFINITY trial (Assessment of Fluoxetine in Stroke Recovery) reported that oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and seizures." | 5.41 | Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke: AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration. ( Almeida, OP; Anderson, CS; Billot, L; Dennis, MS; Etherton-Beer, C; Flicker, L; Ford, AH; Gommans, J; Hackett, ML; Hankey, GJ; Jan, S; Lundström, E; Lung, T; Mead, GE; Sunnerhagen, KS; Thang-Nguyen, H; Yi, Q, 2021) |
"Peak power and fatigue index increased, and VO(2max) and VT did not change with both fluoxetine and amitriptyline." | 5.12 | Comparison of the effects of two antidepressants on exercise performance of the female patients with fibromyalgia. ( Gökbel, H; Levendoğlu, F; Okudan, N; Ozerbil, O, 2006) |
" This open-label study evaluated the efficacy and safety of modafinil treatment initiated with an SSRI in patients with MDD and fatigue." | 5.11 | Adjunctive modafinil at initiation of treatment with a selective serotonin reuptake inhibitor enhances the degree and onset of therapeutic effects in patients with major depressive disorder and fatigue. ( Glass, SJ; Hassman, HA; McManus, FC; Ninan, PT, 2004) |
"One hundred twenty-three men with HIV/AIDS with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition depressive disorder entered the 8-week trial and were randomized to testosterone (up to 400 mg IM testosterone cypionate biweekly), fluoxetine (up to 60 mg/d), or double placebo." | 5.11 | Testosterone versus fluoxetine for depression and fatigue in HIV/AIDS: a placebo-controlled trial. ( Lin, SH; McElhiney, MC; Rabkin, JG; Rabkin, R; Wagner, GJ, 2004) |
"To determine whether fluoxetine, at any dose, given within the first year after stroke to patients who did not have to have mood disorders at randomization reduced disability, dependency, neurological deficits and fatigue; improved motor function, mood, and cognition at the end of treatment and follow-up, with the same number or fewer adverse effects." | 5.05 | Fluoxetine for stroke recovery: Meta-analysis of randomized controlled trials. ( Barugh, A; Dennis, MS; Hackett, ML; Hankey, GJ; Hsieh, CF; Kutlubaev, M; Legg, L; Lundström, E; Mead, GE; Rudberg, AS; Soleimani, B; Tilney, R; Wu, S, 2020) |
"Serotonin, a neurotransmitter synthesized from tryptophan, has been proposed to play a key role in central fatigue." | 3.78 | Essential role of excessive tryptophan and its neurometabolites in fatigue. ( Azechi, H; Board, M; Yamamoto, T, 2012) |
"Aripiprazole is an effective and safe adjunctive therapy as demonstrated in this short-term study for patients who are nonresponsive to standard ADT." | 2.73 | The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study. ( Berman, RM; Carson, WH; Fava, M; Hennicken, D; Marcus, RN; McQuade, RD; Simon, JS; Thase, ME; Trivedi, MH, 2008) |
"Fatigue is a common symptom in primary biliary cirrhosis (PBC)." | 2.72 | Fluoxetine for the treatment of fatigue in primary biliary cirrhosis: a randomized, double-blind controlled trial. ( Donlinger, JJ; Gossard, AA; Jorgensen, RA; Keach, JC; Lindor, KD; Petz, JC; Talwalkar, JA, 2006) |
"At the end of the treatment, EDSS, fatigue and depression scores were further evaluated." | 2.71 | Fatigue in multiple sclerosis: multidimensional assessment and response to symptomatic treatment. ( Alfonsi, E; Bergamaschi, R; Callieco, R; Candeloro, E; Cosi, V; Romani, A, 2004) |
"Treatment with fluoxetine had no effect on tumor growth, muscle wasting, fatigue behavior, or cytokine expression in the brain." | 1.42 | Fluoxetine prevents the development of depressive-like behavior in a mouse model of cancer related fatigue. ( Bicer, S; Devine, R; Godbout, JP; Jing, R; McCarthy, DO; Norden, DM; Reiser, PJ; Wold, LE, 2015) |
"Fluoxetine, which has a long half-life, was more difficult to titrate." | 1.28 | Apathy and indifference in patients on fluvoxamine and fluoxetine. ( Hoehn-Saric, R; Lipsey, JR; McLeod, DR, 1990) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 4 (20.00) | 18.2507 |
2000's | 10 (50.00) | 29.6817 |
2010's | 3 (15.00) | 24.3611 |
2020's | 3 (15.00) | 2.80 |
Authors | Studies |
---|---|
Lundström, E | 3 |
Isaksson, E | 1 |
Greilert Norin, N | 1 |
Näsman, P | 1 |
Wester, P | 1 |
Mårtensson, B | 1 |
Norrving, B | 1 |
Wallén, H | 1 |
Borg, J | 1 |
Hankey, GJ | 3 |
Hackett, ML | 3 |
Mead, GE | 3 |
Dennis, MS | 3 |
Sunnerhagen, KS | 2 |
Legg, L | 1 |
Tilney, R | 1 |
Hsieh, CF | 1 |
Wu, S | 1 |
Rudberg, AS | 1 |
Kutlubaev, M | 1 |
Soleimani, B | 1 |
Barugh, A | 1 |
Almeida, OP | 1 |
Flicker, L | 1 |
Etherton-Beer, C | 1 |
Ford, AH | 1 |
Billot, L | 1 |
Jan, S | 1 |
Lung, T | 1 |
Anderson, CS | 1 |
Thang-Nguyen, H | 1 |
Gommans, J | 1 |
Yi, Q | 1 |
Norden, DM | 1 |
Devine, R | 1 |
Bicer, S | 1 |
Jing, R | 1 |
Reiser, PJ | 1 |
Wold, LE | 1 |
Godbout, JP | 1 |
McCarthy, DO | 1 |
Kim, NH | 1 |
Moon, PD | 1 |
Pak, SC | 1 |
Kim, HM | 1 |
Jeong, HJ | 1 |
Yamamoto, T | 1 |
Azechi, H | 1 |
Board, M | 1 |
Ninan, PT | 1 |
Hassman, HA | 1 |
Glass, SJ | 1 |
McManus, FC | 1 |
Rabkin, JG | 1 |
Wagner, GJ | 1 |
McElhiney, MC | 1 |
Rabkin, R | 1 |
Lin, SH | 1 |
Joliat, MJ | 1 |
Brown, EB | 1 |
Miner, CM | 1 |
Romani, A | 1 |
Bergamaschi, R | 1 |
Candeloro, E | 1 |
Alfonsi, E | 1 |
Callieco, R | 1 |
Cosi, V | 1 |
Ozerbil, O | 1 |
Okudan, N | 1 |
Gökbel, H | 1 |
Levendoğlu, F | 1 |
Talwalkar, JA | 1 |
Donlinger, JJ | 1 |
Gossard, AA | 1 |
Keach, JC | 1 |
Jorgensen, RA | 1 |
Petz, JC | 1 |
Lindor, KD | 1 |
Choi-Kwon, S | 1 |
Choi, J | 1 |
Kwon, SU | 1 |
Kang, DW | 1 |
Kim, JS | 1 |
Marcus, RN | 1 |
McQuade, RD | 1 |
Carson, WH | 1 |
Hennicken, D | 1 |
Fava, M | 1 |
Simon, JS | 1 |
Trivedi, MH | 1 |
Thase, ME | 1 |
Berman, RM | 1 |
Azaz-Livshits, TL | 1 |
Danenberg, HD | 1 |
Judge, R | 1 |
Plewes, JM | 1 |
Kumar, V | 1 |
Koke, SC | 1 |
Kopp, JB | 1 |
Meeusen, R | 1 |
Piacentini, MF | 1 |
Van Den Eynde, S | 1 |
Magnus, L | 1 |
De Meirleir, K | 1 |
Berlin, RM | 1 |
King, SL | 1 |
Blythe, DG | 1 |
Hoehn-Saric, R | 1 |
Lipsey, JR | 1 |
McLeod, DR | 1 |
Kahn, DG | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Establishing the Effect(s) and Safety of Fluoxetine Initiated in the Acute Phase of Stroke[NCT02683213] | Phase 3 | 1,500 participants (Actual) | Interventional | 2014-10-20 | Completed | ||
Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis. Randomized, Blinded, Placebo-controlled Clinical Trial.[NCT02280096] | Phase 2 | 24 participants (Actual) | Interventional | 2014-10-31 | Completed | ||
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder[NCT00095758] | Phase 3 | 1,200 participants | Interventional | 2004-09-30 | Completed | ||
A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy (ADT) Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior ADT[NCT00683852] | Phase 3 | 225 participants (Actual) | Interventional | 2008-09-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Measure sustained attention. The CTT uses numbered coloured circles and universal sign language symbols. The circles are printed with vivid pink or yellow backgrounds that are perceptible to colourblind individuals. For the Colour Trails 1 trial, the respondent uses a pencil to rapidly connect circles numbered 1 through 25 in sequence. Less time indicates better performance (min=10, max= 240). (NCT02280096)
Timeframe: 5-8 minutes
Intervention | units on a scale (seconds) (Mean) |
---|---|
4-aminopyridine | 68.91 |
Placebo | 67.3 |
The Fatigue Severity Scale (FSS) is one of the most frequently used inventories for measuring fatigue in people with chronic illnesses. The FSS questionnaire is comprised of nine statements inquiring about the examinee's sleep habits over the preceding week. Ratings are on a 7-point Likert scale, where higher scores indicate how strongly the patient agrees with the nine statements.Scale. Scoring using a bimodal response system or a Likert score with weights assigned to each response choice. Likert or bimodal rating scales with 4 response options. For the Likert Scale: better than usual= 0, no more than usual= 1, worse than usual= 2, much worse than usual= 3. For the bimodal scale: better than usual= 0, no more than usual= 0, worse than usual= 1, much worse than usual= 1. Sum all items for a total score. Score range. Range is 0 -11 for bimodal response format. Interpretation of scores. Higher score indicates more fatigue. Self report scale (NCT02280096)
Timeframe: 10 minutes
Intervention | score on a scale (Mean) |
---|---|
4-aminopirydine | 4.3 |
Placebo | 3.3 |
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The first levels 1.0 to 4.5 refers to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refers to the loss of ambulatory ability. It also provides eight subscale measurements called Functional System (FS) scores. The levels of function within each category refer to the eight FS affected by MS: The FS are scored on a scale of 0 (low level of problems) to 5 (high level of problems) to best reflect the level of disability observed clinically. (NCT02280096)
Timeframe: 15-20 minutes
Intervention | score on a scale (Mean) |
---|---|
4-aminopyridine Treatment | 4.6 |
Placebo | 4.04 |
Integrated Program of Neuropsychological Exploration Test Barcelona: Digit Span Forward (DSF), (attention spam and improved scoring metrics significantly enhance the precision of DSF assessments of short-term verbal memory). Digit sequences are presented beginning with a length of two digits and two trials are presented at each increasing list length. Max score 8 and min score 0 digits. Higher scores indicate a better cognitive performance. (NCT02280096)
Timeframe: 7-10 min
Intervention | correct numbers recalled (Mean) |
---|---|
4-aminopyridine | 6.1 |
Placebo | 5 |
The purpose of this test is to assess visual-spatial constructional ability and visual memory. The time required to copy the drawing is recorded. Less time indicates a better performance and more time indicates a worse outcome (min score 60 and max score 300 seconds). (NCT02280096)
Timeframe: 10-15 minutes
Intervention | units on a scale (seconds) (Mean) |
---|---|
4-aminopyridine | 208.6 |
Placebo | 231.2 |
Neuropsychological tests to assess: verbal fluency. Participants have to say as many words as possible from a category in a given time 60 Sec (F, A, S) Max score 72 and min score 19 words. Higher scores indicate a better cognitive performance. (NCT02280096)
Timeframe: 10-15 minutes
Intervention | Correct words (Mean) |
---|---|
4-aminopyridine | 42.09 |
Placebo | 35.5 |
Timed 25 Foot Walk Test (T25-FW). The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. TIME LIMIT PER TRIAL (2) 3 minutes (180 seconds) per trial. (NCT02280096)
Timeframe: 5-10 minutes
Intervention | seconds (Mean) |
---|---|
4-aminopyridine | 15.2 |
Placebo | 10.4 |
"Is used primarily to assess perseveration and abstract thinking, allows the clinician to assess the following 'frontal' lobe functions: strategic planning, organised searching, utilising environmental feedback to shift cognitive sets, directing behaviour toward achieving a goal. WCST measures abstract reasoning and ability to alter problem solving strategies. Patients are given 128 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. The examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. Higher scores indicate a worse cognitive performance (min=0-3, max=58-126)" (NCT02280096)
Timeframe: 10-15 minutes
Intervention | score on a scale (Mean) |
---|---|
4-aminopyridine | 19.8 |
Placebo | 22.8 |
Processing speed information (which includes reading, count, and alternation speed). Cards with a different number of stimuli are shown to the patient, who has to read, count, and respond to a change of instructions (alternation). Reading speed (min 12, max 31+ seconds), counting speed (min 14, max 28+ seconds), and alternation speed (min 26, max 56+ seconds) are recorded. Less speed corresponds to a better outcome. (NCT02280096)
Timeframe: 8-10 min
Intervention | seconds (Mean) | ||
---|---|---|---|
Reading speed | Count speed | Alternation speed | |
4-aminopirydine | 28 | 30.5 | 60.3 |
Placebo | 29.6 | 34.2 | 58.8 |
Safety surveillance will be done every two weeks from the beginning of the study, intentionally searching for adverse events (AE). EEG (Diffuse or focal cerebral dysfunction through demonstration of background slowing or presence of epileptiform activity assessed by a neurophysiologist) and laboratory tests (Presence of values higher of the normal value established by local laboratory and related to the administration of treatments), blood and urine samples: creatinine, blood urea nitrogen, total cholesterol, triglycerides, total direct, and indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, creatinine kinase, lactic acid dehydrogenase, amylase and lipase. A complete blood cell count with differentials and a routine urinalysis and urine culture also obtained at each visit, will be done before the patients take 40, 50 and 60 mg/day. The number of participants with abnormal studies were reported. (NCT02280096)
Timeframe: 22 weeks
Intervention | Participants (Count of Participants) | |
---|---|---|
Number of participants with abnormal lab results | Number of participants with abnormal EEG | |
4-aminopyridine Treatment | 1 | 0 |
Placebo | 0 | 0 |
Measures higher-order problem-solving ability. The information it provides is not only useful when assessing frontal lobe damage, but also when evaluating attention disorders and executive functioning difficulties. The administrator arranges red, green, and blue beads on a peg board to match the configuration in the diagram. The patient is asked to replicate the configuration on a second peg board. Scores are calculated for Total Execution Time (since the patient performs the first move until he ends the test), Total Problem-Solving Time (the sum of planning and execution times). Total execution time higher scores indicate a worse outcome (min= 0-78, max=564+ seconds), Total problem-solving time higher scores indicate a worse outcome (min= 0-56, max=500+ seconds). (NCT02280096)
Timeframe: 25-30 minutes
Intervention | seconds (Mean) | |
---|---|---|
Total execution time | Total problem-solving time | |
4-aminopyridine | 296.2 | 363.3 |
Placebo | 367.9 | 426.8 |
Measures higher order problem-solving ability. The information it provides is not only useful when assessing frontal lobe damage, but also when evaluating attention disorders and executive functioning difficulties. The administrator arranges red, green, and blue beads on a peg board to match the configuration in the diagram. The patient is asked to replicate the configuration on a second peg board. Scores are calculated for Total Correct Moves and Total Moves. Total moves: higher scores indicate a worse cognitive performance (min= 0, max=58+); Total correct higher scores indicate a better cognitive performance (min=0, max=10). (NCT02280096)
Timeframe: 25-30 minutes
Intervention | score on a scale (Mean) | |
---|---|---|
Total moves | Correct moves | |
4-aminopyridine | 42.7 | 4 |
Placebo | 50.8 | 3 |
MADRS readmission rate is defined as MADRS score<11. The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression. (NCT00683852)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|---|
Phase 1 Drug | 4 |
Phase 1 Placebo Non-Responders on Drug in Phase 2 | 8 |
Phase I Placebo | 16 |
Phase 1 Placebo Non-Responders on Placebo in Phase 2 | 4 |
The primary outcome was the difference in response rate (decrease in MADRS total score of at least 50%) using the SPCD (sequential parallel comparison design). The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression. (NCT00683852)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|---|
Phase 1 Drug | 10 |
Phase 1 Placebo Non-Responders on Drug in Phase 2 | 11 |
Phase I Placebo | 29 |
Phase 1 Placebo Non-Responders on Placebo in Phase 2 | 5 |
The CGI-S scale was administered by clinicians based on assessment of the patient's clinical status. They measured, based on history and scores on other instruments, depressive severity. It consists of one question scored on a seven-point scale (1 = normal to 7 = among the most severe), so a higher total score indicates greater depressive severity. The minimum score is 1, and the maximum score is 7. (NCT00683852)
Timeframe: Baseline and 12 weeks
Intervention | units on a scale (Mean) |
---|---|
Phase 1 Drug | -0.81 |
Phase 1 Placebo Non-Responders on Drug in Phase 2 | -0.64 |
Phase I Placebo | -0.84 |
Phase 1 Placebo Non-Responders on Placebo in Phase 2 | -0.43 |
The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression. (NCT00683852)
Timeframe: Baseline and 12 Weeks
Intervention | units on a scale (Mean) |
---|---|
Phase 1 Drug | -8.54 |
Phase 1 Placebo Non-Responders on Drug in Phase 2 | -5.80 |
Phase I Placebo | -8.09 |
Phase 1 Placebo Non-Responders on Placebo in Phase 2 | -3.32 |
Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis compared AEs between the arms that received exclusively drug throughout the study or placebo throughout the study. (NCT00683852)
Timeframe: 12 Weeks
Intervention | Patients (Number) |
---|---|
ADAPT Drug/Drug Group | 39 |
ADAPT Placebo/Placebo Group | 60 |
Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis focused on placebo non-responders in phase 1 and presented them by their treatment assignment in phase 2. (NCT00683852)
Timeframe: 12 Weeks
Intervention | Patients (Number) |
---|---|
Phase 1 Placebo Non-Responders on Drug in Phase 2 | 40 |
Phase 1 Placebo Non-Responders on Placebo in Phase 2 | 44 |
Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. In this analysis, AEs were summarized according to person-phase of occurrence. Each AE was attributed to the person and then to phase 1 or phase 2, depending on the initial date of onset. (NCT00683852)
Timeframe: 12 Weeks
Intervention | adverse events (Number) |
---|---|
ADAPT Drug Group | 58 |
ADAPT Placebo Group | 110 |
The SQ, a 92-item (yes/no) self-rating questionnaire, includes 4 distress and 4 well-being subscales. There are 68 items for the distress subscales and 24 items for the well-being subscales. Each item has either a Yes/No or True/False answer. For the distress symptom score, add together the following items and score 1 when the answer is Yes/True: 1, 2, 3, 5, 6, 8, 11, 12, 15, 18, 20, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 34, 36, 37, 39, 41, 42, 44, 45, 47, 48, 49, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 72, 73, 74, 75, 76, 77, 79, 80, 81, 82, 84, 85, 86, 87, 88, 90, 91, 92. Minimum score is 0 and maximum score is 68. A higher score indicates more distress symptoms. For the well-being subscale score, add together the following items and score 1 when the answer is No/False: 4, 7, 9, 10, 13, 14, 16, 17, 19, 21, 23, 29, 31, 35, 38, 40, 43, 46, 50, 51, 71, 78, 83, 89. Minimum score is 0 and maximum score is 24. A higher score indicates more well-being. (NCT00683852)
Timeframe: Baseline and 12 weeks
Intervention | units on a scale (Mean) | |
---|---|---|
Sum of 4 subscaled distress scores | Sum of 4 subscaled well-being scores | |
Phase 1 Drug | -9.44 | 3.71 |
Phase 1 Placebo Non-Responders on Drug in Phase 2 | -6.78 | 3.34 |
Phase 1 Placebo Non-Responders on Placebo in Phase 2 | -4.52 | 1.98 |
Phase I Placebo | -9.70 | 2.75 |
1 review available for fluoxetine and Fatigue
Article | Year |
---|---|
Fluoxetine for stroke recovery: Meta-analysis of randomized controlled trials.
Topics: Fatigue; Fluoxetine; Humans; Randomized Controlled Trials as Topic; Stroke; Stroke Rehabilitation | 2020 |
10 trials available for fluoxetine and Fatigue
Article | Year |
---|---|
Effects of Fluoxetine on Outcomes at 12 Months After Acute Stroke: Results From EFFECTS, a Randomized Controlled Trial.
Topics: Affect; Aged; Aged, 80 and over; Depression; Double-Blind Method; Fatigue; Female; Fluoxetine; Healt | 2021 |
Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke: AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration.
Topics: Accidental Falls; Affect; Aged; Cognition; Double-Blind Method; Fatigue; Female; Fluoxetine; Fractur | 2021 |
Adjunctive modafinil at initiation of treatment with a selective serotonin reuptake inhibitor enhances the degree and onset of therapeutic effects in patients with major depressive disorder and fatigue.
Topics: Adolescent; Adult; Aged; Benzhydryl Compounds; Central Nervous System Stimulants; Depressive Disorde | 2004 |
Testosterone versus fluoxetine for depression and fatigue in HIV/AIDS: a placebo-controlled trial.
Topics: Acquired Immunodeficiency Syndrome; Adult; Chi-Square Distribution; Depressive Disorder; Double-Blin | 2004 |
Fatigue in multiple sclerosis: multidimensional assessment and response to symptomatic treatment.
Topics: 4-Aminopyridine; Adult; Antidepressive Agents, Second-Generation; Cognition; Depression; Disability | 2004 |
Comparison of the effects of two antidepressants on exercise performance of the female patients with fibromyalgia.
Topics: Adult; Amitriptyline; Antidepressive Agents; Cross-Over Studies; Double-Blind Method; Exercise Test; | 2006 |
Fluoxetine for the treatment of fatigue in primary biliary cirrhosis: a randomized, double-blind controlled trial.
Topics: Adolescent; Adult; Aged; Double-Blind Method; Fatigue; Fluoxetine; Humans; Liver Cirrhosis, Biliary; | 2006 |
Fluoxetine is not effective in the treatment of post-stroke fatigue: a double-blind, placebo-controlled study.
Topics: Affective Symptoms; Anger; Antidepressive Agents, Second-Generation; Depression; Double-Blind Method | 2007 |
The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study.
Topics: Adult; Akathisia, Drug-Induced; Antidepressive Agents; Aripiprazole; Citalopram; Cyclohexanols; Depr | 2008 |
The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study.
Topics: Adult; Akathisia, Drug-Induced; Antidepressive Agents; Aripiprazole; Citalopram; Cyclohexanols; Depr | 2008 |
The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study.
Topics: Adult; Akathisia, Drug-Induced; Antidepressive Agents; Aripiprazole; Citalopram; Cyclohexanols; Depr | 2008 |
The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study.
Topics: Adult; Akathisia, Drug-Induced; Antidepressive Agents; Aripiprazole; Citalopram; Cyclohexanols; Depr | 2008 |
Exercise performance is not influenced by a 5-HT reuptake inhibitor.
Topics: Adult; Analysis of Variance; beta-Endorphin; Bicycling; Cross-Over Studies; Double-Blind Method; Exe | 2001 |
9 other studies available for fluoxetine and Fatigue
Article | Year |
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Fluoxetine prevents the development of depressive-like behavior in a mouse model of cancer related fatigue.
Topics: Adenocarcinoma; Administration, Oral; Animals; Antidepressive Agents, Second-Generation; Brain; Colo | 2015 |
Anti-fatigue effect of Zizania caudiflora (Turczaninow) Nakai.
Topics: Albumins; Animals; Blood Glucose; Blood Proteins; Blood Urea Nitrogen; Creatine Kinase; Fatigue; Flu | 2012 |
Essential role of excessive tryptophan and its neurometabolites in fatigue.
Topics: Acetylglucosaminidase; Amino Acids, Branched-Chain; Analysis of Variance; Animals; Corpus Striatum; | 2012 |
Changes in energy after switching from daily citalopram, paroxetine, or sertraline to once-weekly fluoxetine.
Topics: Citalopram; Depressive Disorder; Drug Administration Schedule; Fatigue; Fluoxetine; Humans; Paroxeti | 2004 |
Tachycardia, orthostatic hypotension and profound weakness due to concomitant use of fluoxetine and nifedipine.
Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Calcium Channel Blockers; Drug Interactions; Drug | 1997 |
Changes in energy during treatment of depression: an analysis of fluoxetine in double-blind, placebo-controlled trials.
Topics: Adult; Aged; Analysis of Variance; Controlled Clinical Trials as Topic; Depressive Disorder, Major; | 2000 |
Symptomatic improvement of chronic fatigue with fluoxetine in ciguatera fish poisoning.
Topics: Chronic Disease; Ciguatera Poisoning; Fatigue; Female; Fluoxetine; Foodborne Diseases; Humans; Male; | 1992 |
Apathy and indifference in patients on fluvoxamine and fluoxetine.
Topics: Adult; Agoraphobia; Antidepressive Agents; Anxiety Disorders; Arousal; Depressive Disorder; Dose-Res | 1990 |
Increased plasma nortriptyline concentration in a patient cotreated with fluoxetine.
Topics: Depressive Disorder; Drug Interactions; Drug Therapy, Combination; Dyspnea; Fatigue; Fluoxetine; Hum | 1990 |