A single center, open label study assessing the feasibility, safety and therapeutic effect of Minocycline in adult patients with diagnosis of unipolar depression. Up to 30 patients diagnosed with unipolar depression that are in a current depressive episode. The patients will be of all racial, ethnic and gender categories, ranging from 18 to 68 years of age, and have HDRS-21≥20. All subjects will continue to take their treatment with antidepressant medications for the duration of the study. All subjects are prescribed minocycline 200 mg/day orally (2X100 mg) for the first 3 days. than, all subjects are prescribed minocycline 400 mg/day orally (2X200 mg) from day 4 until termination visit (day 35). The primary objective of this study is to assess the therapeutic effect of Minocycline in unipolar depression. The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of Minocycline in unipolar depression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Minocycline 200 mg/day (2X100 mg) from day 1 to day 3 and Minocycline 400 mg/day (2X200mg) form day 4 until termination visit (day 35)
Shalvata Medical Health Center
Hod HaSharon, Israel
RECRUITINGDepression symptoms
The change in Scale for Depression (HDRS-21) score from baseline to the end of the study (visit 4 - day 35) where response is defined as ≤50% reduction in HDRS-21 score from baseline.
Time frame: from baseline (day 1) to termination (day 35)
Depression symptoms - CGI
The change in Clinical Global Impression Scale (CGI) from baseline to the end of the study.
Time frame: from baseline (day 1) untill termination visit (day 35)
depression symptoms - (QIDS-SR)
The change in Quick Inventory of Depressive Symptology -self report (QIDS-SR) from baseline to the end of the study.
Time frame: from baseline (day 1) untill termination visit (day 35)
depression symptoms - HDRS-21
Remission rates after 5 weeks of Minocycline treatment, where remission is defined as HDRS-21 score \<10.
Time frame: from baseline (day 1) untill termination visit (day 35)
Safety
Safety Evaluation: Tolerability of Minocycline as defined by maintained subject baseline, pre-treatment, physical and neurological examinations and lack of significant increase in suicide ideation measured by: * Vital signs * Physical and neurological examination * Any other adverse events (AEs).
Time frame: frpm baseline (day 1) untill the termination visit (day 35)
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