To evaluate whether Desvenlafaxine can reduce the frequency and severity of migraine attacks in patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
440
Desvenlafaxine
placebo
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
the change from baseline in monthly migraine days during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
the change from baseline in monthly migraine days during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Days with migraine every 4 weeks during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Days with migraine every 4 weeks during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Moderate/severe headache days during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Moderate/severe headache days during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
The rate of effective responders during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Treatment effectiveness criterion: reduction in headache days by ≥50% during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Headache severity during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
The VAS score reflects the severity of headache pain during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
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Time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Cumulative headache duration during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Based on the headache diary recordings, the cumulative duration of headache episodes will be summed to calculate the total headache time during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Change in Anxiety and Depression Scores
Change from baseline in anxiety and depression levels, assessed by the Hospital Anxiety and Depression Scale (HADS). Total score ranges from 0 to 21 for anxiety and 0 to 21 for depression subscales, where 0-7 = normal, 8-10 = borderline, 11-21 = abnormal. Higher scores indicate worse anxiety/depression.
Time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Changes in daily life behavioral capabilities
The HIT-6 questionnaire measures the adverse impact of headache on daily functioning in six domains (pain, social functioning, role functioning, vitality, cognitive functioning, psychological distress).
Time frame: During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)