Biomaterial Database

Fluoxetine dose and outcome in antidepressant drug trials. 2002

Corrado Barbui, and Matthew Hotopf, and Silvio Garattini

"Mario Negri" Institute for Pharmacological Research, Milan, Italy. corrado.barbui@univr.it

OBJECTIVE One potential for bias in the evaluation of a new drug is the dose used, both for the new compound and for the reference drug. The present study compared fluoxetine dose and outcome in trials in which fluoxetine was the experimental drug with trials in which it was the comparator. METHODS Systematic review of randomised controlled trials comparing fluoxetine with any other antidepressant in depressive patients. Studies were allocated to one of the following two groups: group 1 = fluoxetine was the experimental drug; group 2 = fluoxetine was the control drug. Trials were located by searching the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Controlled Trials Register. RESULTS The systematic search yielded 103 randomised trials. Studies in which fluoxetine was the experimental drug adopted a higher dose regimen than group-2 studies. In the efficacy analysis, the weighted rate of fluoxetine responders was 70.1% (confidence interval 67.4%, 72.8%) in group-1 studies and 57.9% (57.2%, 58.7%) in group-2 studies. In the effectiveness analysis, the weighted rate of fluoxetine responders was 56.4% (55.3%, 57.6%) in group-1 studies and 51.9% (51.2%, 52.7%) in group-2 studies. The weighted rate of fluoxetine dropouts was higher in group-1 studies. CONCLUSIONS . Fluoxetine dose and outcome changed according to whether this drug was used as a new compound or as a reference.

UI	MeSH Term	Description	Entries
D003863	Depression	Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders.	Depressive Symptoms,Emotional Depression,Depression, Emotional,Depressive Symptom,Symptom, Depressive
D005473	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.	Fluoxetin,Fluoxetine Hydrochloride,Lilly-110140,N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine,Prozac,Sarafem,Lilly 110140,Lilly110140
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000929	Antidepressive Agents, Tricyclic	Substances that contain a fused three-ring moiety and are used in the treatment of depression. These drugs block the uptake of norepinephrine and serotonin into axon terminals and may block some subtypes of serotonin, adrenergic, and histamine receptors. However, the mechanism of their antidepressant effects is not clear because the therapeutic effects usually take weeks to develop and may reflect compensatory changes in the central nervous system.	Antidepressants, Tricyclic,Tricyclic Antidepressant,Tricyclic Antidepressant Drug,Tricyclic Antidepressive Agent,Tricyclic Antidepressive Agents,Antidepressant Drugs, Tricyclic,Agent, Tricyclic Antidepressive,Agents, Tricyclic Antidepressive,Antidepressant Drug, Tricyclic,Antidepressant, Tricyclic,Antidepressive Agent, Tricyclic,Drug, Tricyclic Antidepressant,Drugs, Tricyclic Antidepressant,Tricyclic Antidepressant Drugs,Tricyclic Antidepressants
D015982	Bias	Any deviation of results or inferences from the truth, or processes leading to such deviation. Bias can result from several sources: one-sided or systematic variations in measurement from the true value (systematic error); flaws in study design; deviation of inferences, interpretations, or analyses based on flawed data or data collection; etc. There is no sense of prejudice or subjectivity implied in the assessment of bias under these conditions.	Aggregation Bias,Bias, Aggregation,Bias, Ecological,Bias, Statistical,Bias, Systematic,Ecological Bias,Outcome Measurement Errors,Statistical Bias,Systematic Bias,Bias, Epidemiologic,Biases,Biases, Ecological,Biases, Statistical,Ecological Biases,Ecological Fallacies,Ecological Fallacy,Epidemiologic Biases,Experimental Bias,Fallacies, Ecological,Fallacy, Ecological,Scientific Bias,Statistical Biases,Truncation Bias,Truncation Biases,Bias, Experimental,Bias, Scientific,Bias, Truncation,Biase, Epidemiologic,Biases, Epidemiologic,Biases, Truncation,Epidemiologic Biase,Error, Outcome Measurement,Errors, Outcome Measurement,Outcome Measurement Error
D016032	Randomized Controlled Trials as Topic	Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.	Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical
D016896	Treatment Outcome	Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.	Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D018687	Antidepressive Agents, Second-Generation	A structurally and mechanistically diverse group of drugs that are not tricyclics or monoamine oxidase inhibitors. The most clinically important appear to act selectively on serotonergic systems, especially by inhibiting serotonin reuptake.	Antidepressants, Atypical,Atypical Antidepressants,Second-Generation Antidepressive Agents,Antidepressive Drugs, Second-Generation,Agents, Second-Generation Antidepressive,Antidepressive Agents, Second Generation,Antidepressive Drugs, Second Generation,Drugs, Second-Generation Antidepressive,Second Generation Antidepressive Agents,Second-Generation Antidepressive Drugs