Comparison between venlafaxine & citaloperam in menopausal women with sleep disorders

Phase 2

• Conditions: Menopause.; Menopausal symptoms

• Registration Number: IRCT201210152576N6
• Lead Sponsor: Deputy research of Tehran university of Medical Sciences

Brief Summary

• Abstract<br /> Send to:<br /> Arch Gynecol Obstet. 2015 Oct 5. [Epub ahead of print]<br /> Comparison of citalopram and venlafaxine's role in treating sleep disturbances in menopausal women, a randomized, double-blind, placebo-controlled trial.<br /> Davari-Tanha F1, Soleymani-Farsani M2, Asadi M3, Shariat M4, Shirazi M2, Hadizadeh H2.<br /> Author information<br /> Abstract<br /> INTRODUCTION:<br /> Sleep disturbance is a common complaint in postmenopausal women. Few studies compared symptom improvement taking antidepressants versus placebo. This study aims to evaluate the efficacy of venlafaxine and Citalopram compared to placebo in treatment of sleep disturbance in healthy postmenopausal women.<br /> METHOD:<br /> This randomized, double-blind, placebo-controlled clinical trial was conducted in three groups of 20 postmenopausal women. The patients took venlafaxine 75 mg/daily (group I) or citalopram 20 mg/d (group II) or placebo (group III). Each patient filled Pittsburgh sleep quality index (PSQI) and Pittsburgh and Beck depression questionnaires. The frequency of hot flashes in a day and its severity were measured through diaries. Somatic symptoms and adverse side effects were evaluated. Follow-up visit was conducted after 3 months. The prior and the later results were compared.<br /> RESULTS:<br /> The PSQI scores in three placebo, venlafaxine, and citalopram groups before treatment were 14.25 ± 3.85, 11.55 ± 3.96, and 13.50 ± 3.56, respectively (p = 0.076). These values after treatment reached 9.95 ± 5.07, 8 ± 3.06, and 6.95 ± 1.84, respectively. PSQI score in citalopram and venlafaxine group was not significantly different (p = 0.19) but the score in both groups was significantly lower compared with placebo group after treatment (p = 0.01). The frequency of hot flashes in a day was reduced significantly by both citalopram and venlafaxine (p < 0.05), although it was more reduced by citalopram than venlafaxine (p = 0.03). Severity of hot flashes in both venlafaxine and citalopram was significantly lower in comparison with placebo group (p = 0.02), and there was no significant difference between two drugs, though (p = 0.84). Beck score decreased more in venlafaxine group in comparison with other groups but it did not reach significant (p = 0.06).<br /> CONCLUSION:<br /> Citalopram and venlafaxine are equally more effective than placebo in reducing sleep disturbance and severity of hot flashes, while citalopram is more effective in reducing frequency of hot flashes than venlafaxine. Meanwhile, venlafaxine is more effective than citalopram in treatment of depression in postmenopausal women.<br /> TRIAL REGISTRATION:<br /> Iranian Registry of Clinical Trials 201210152576N6.<br /> KEYWORDS:<br /> Citalopram; Menopause; Sleep disturbances; Venlafaxine<br /> <br />

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Inclusion criterion: menopausal women with sleep disorders.
Exclusion criteria: women who use benzodiazepines or they have history of depression.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep disorders. Timepoint: Before intervention, 8 and 12 weeks after intervention. Method of measurement: Pittsburgh's questionnaire.