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Femoxetine and amitriptyline in general practice: a randomized double-blind group comparison
Insights
This study found that femoxetine and amitriptyline showed similar effectiveness for major depressive disorder over six weeks. Amitriptyline had a faster initial effect on sleep symptoms, but both drugs had comparable dropout rates due to side effects.
Area of Science:
- Psychiatry
- Clinical Pharmacology
Background:
- Major depressive disorder (MDD) is a prevalent mental health condition requiring effective treatment options.
- Selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs) are common pharmacological approaches.
Purpose of the Study:
- To compare the efficacy and tolerability of femoxetine (an SSRI) versus amitriptyline (a TCA) in patients with definite major depressive disorder.
- To assess treatment outcomes using the Hamilton Depression Scale (HDS) and clinical global assessment.
Main Methods:
- A randomized, double-blind, group comparative study involving 81 patients diagnosed with definite major depressive disorder.
- Patients received either 600 mg daily of femoxetine or 150 mg daily of amitriptyline for six weeks.
- Efficacy was measured by HDS scores and global assessments; side effects and dropout rates were also recorded.
Main Results:
- No statistically significant differences in overall efficacy were observed between femoxetine and amitriptyline after six weeks.
- Amitriptyline demonstrated a significantly greater reduction in HDS sleep item scores at week 2.
- Dropout rates due to side effects were similar (14-15%), though femoxetine had fewer reported side effects overall (38% vs. 14%).
Conclusions:
- Femoxetine and amitriptyline exhibit comparable overall efficacy for major depressive disorder in general practice settings over a six-week period.
- Amitriptyline may offer a faster onset of action, particularly concerning sleep disturbances.
- Both treatments present distinct side effect profiles, with femoxetine associated with nausea and amitriptyline with anticholinergic effects; femoxetine did not cause weight gain.
Abstract:
Patients with a depressive illness with 4 major symptoms of depression and a score of at least 17 on the Hamilton Depression Scale (1-17) (HDS) were allocated to a randomized double-blind group comparative study in general practice. After retrospective analysis, all 81 patients except one were characterized as suffering from a 'Definite Major Depressive Disorder', as defined by Spitzer et al. (1978). After 6 weeks of treatment with a daily dosage of 600 mg femoxetine or 150 mg amitriptyline, no statistically significant differences between the 2 treatment groups were observed, either when using the HDS or the clinical global assessment scale. Confidence limits of 95% for differences between therapeutic effect showed a non-significant tendency in favour of amitriptyline. During treatment, there were statistically significant differences in the reduction of HDS score between the 2 treatments in week 2. These differences were the result of amitriptyline's significantly greater effect on the 3 sleep items at week 2, as indicated by the results of single item analysis. Drop out rates due to side effects were between 14-15% in both treatment groups. Of the patients treated with femoxetine, 38% experienced no side effects, compared to 14% of patients treated with amitriptyline. Nausea was the side effect most commonly reported by patients treated with femoxetine, whereas a significantly greater frequency of anticholinergic side effects was recorded during treatment with amitriptyline (P less than 0.05). Unlike amitriptyline, femoxetine did not increase body weight. Treatment with the active drug was continued after the trial period in 14 and 18 patients in the femoxetine and amitriptyline groups respectively.