Comparison of therapeutic effects and side effects between fluoxetine hydrochloride and clomipramine in patients with vascular depression

Luli HUANG

ABSTRACT

BACKGROUND:

Most of patients with depression suffer from cardiovascular or cerebrovascular diseases. This kind of depression is conceptualized as vascular depression. Specific 5-hydroxytryptamine (5-HT) uptake inhibitors are proved to have a definite therapeutic effect on depression, but their influence on vascular depression need to be confirmed.

OBJECTIVE:

To compare the therapeutic effects and side effects between fluoxetine hydrochloride and clomipramine in patients with vascular depression.

DESIGN:

Randomized controlled investigation.

SETTING:

It was conducted at the Cardiological Department of the First Hospital Affiliated to Xinxiang Medical College.

PARTICIPANTS:

From January 2003 to December 2004, inpatients and outpatients at the Cardiology Department of the First Hospital Affiliated to Xinxiang Medical College were selected. Inclusion criteria ① a diagnosis of depression according to the diagnostic criteria of the Chinese Classification of Mental Disorder (CCMD); ② a diagnosis of vascular depression according to the clinical definition suggested by Alexopoulos et al[1], which is,before the onset of depression, cardiovascular diseases or cerebrovascular diseases have been evidenced already;③ with an age less than 70 years old; ④ and getting informed consents from the patients and their relatives.Exclusion criteria ① having a history of drug allergy;② having consciousness disorders and obvious dementia symptoms; ③ having severe impairment in cardiac function, hepatic function or renal function; ④ having severe mental disorders, ⑤ and having trauma, tumor, inflammation or demyelination in brain, and a history of depression. Sixty eligible patients were selected and divided into the experimental group and the control group, 30 patients in each group.

METHODS:

With promoting-blood-circulation-to-remove-blood-stasis medication, patients in experimental group took oral fluoxetine hydrochloride (20 mg/day) while patients in control group took oral clomipramine (starting with a dose of 25 mg/time and then adding to 50-250 mg/day, tid, according to the state of illness and the patients' tolerance), the duration of the medication in each group was 12 weeks. Before treatment and at posttreatment week 4, 6 and 12, the therapeutic effects on depression were assessed using Hamilton Depression (HAMD) Rating Scale respectively, and pre-treatment and post-treatment adverse reactions and side effects were recorded as well. Descriptive data were shown as percentage, comparison between groups was performed using Chi-square test, and measurement data was compared with t Test.MAIN OUTCOME

MEASURES:

Primary outcomes included ① Comparison of pre- and post-treatment HAMD scores between the two groups.groups.② Comparison of post-treatment therapeutic effects between the two groups.Secondary outcomes included adverse events and side effects.

RESULTS:

In each group, 30 patients completed the medication and entered the statistical analysis procedure.① Comparison of HAMD scores between the two groups In experimental group, the HAMD scores at posttreatment week 6 and 12 were lower than the pre-treatment scores (12.40±4.30, 7.80±4.36 and 21.30±2.64; P ＜ 0.01), and lower than those in control group (at post-treatment week 6 13.20±4.90; at post-treatment week 12 7.90±4.20; t=3.98, 5.02, P ＜ 0.01). ②Comparison of improvement in depression between the two groups In experimental group, the effective rate at post-treatment week 6 and 12 were higher than those in control group (week 6 93％ and 87％; week 12 97％ and 93％, P ＞ 0.05). ③Comparison of adverse events and side effects between the two groups In experimental group, there were 8 patients had adverse events and side effects, 2 of them might be linked to the medication, with manifestation of nausea and thirsty. In control group, the number was 13, 10 of them might be linked to the medication, with manifestation of thirsty, constipation,voiding dysfunction, dizziness and excitation. The occurrence rate of side effects was lower in therapeutic group than in control group (27% and 43%, P ＜ 0.01).

CONCLUSION:

The therapeutic effect of fluoxetine hydrochloride was close to that of clomipramine. And the patients' tolerance to fluoxetine hydrochloride is better than their tolerance to clomipramine.