Open Study Assessing the Feasibility of Minocycline in Patients With Unipolar Depression
A Single Center, Open Label Study Assessing the Feasibility, Safety and Therapeutic Effect of Minocycline in Adult Patients With Diagnosis of Unipolar Depression.
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJuly 4, 2012
April 1, 2012
2 years
April 9, 2012
July 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Depression 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.
from baseline (day 1) to termination (day 35)
Secondary Outcomes (4)
Depression symptoms - CGI
from baseline (day 1) untill termination visit (day 35)
depression symptoms - (QIDS-SR)
from baseline (day 1) untill termination visit (day 35)
depression symptoms - HDRS-21
from baseline (day 1) untill termination visit (day 35)
Safety
frpm baseline (day 1) untill the termination visit (day 35)
Study Arms (1)
Minocycline
EXPERIMENTALMinocycline 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)
Interventions
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)
Eligibility Criteria
You may qualify if:
- Outpatients and inpatients
- Men and women 18-68 years of age.
- Primary DSM-IV diagnosis of Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
- Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit.
- The patient did not respond to at least one antidepressant medication given for an accepted dose and duration.
- Capable and willing to provide informed consent
- Able to adhere to the treatment schedule.
You may not qualify if:
- Depression secondary to a general medical condition.
- History of substance abuse or dependence within the past 6 month (except opioids, nicotine and caffeine).
- All antidepressant medications, must have been in stable dosage for at least 3 weeks prior to entry into the study, with no anticipation of change over the duration of the study.
- Use of any medication(s) listed on the Excluded medication list within the time that mansion for each medication on the list.
- Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • Bipolar disorder • Eating disorder
- Subjects who were taking a known contraindication to minocycline treatment.
- Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
- Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 6 month
- Known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.(if using oral contraceptives, during the minocycline treatment, subject should use an additional contraceptives), or women who are breastfeeding
- Patients with severe hepatic or renal insufficiency.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shalvata Medical Health Center
Hod HaSharon, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yechiel Levkovitz, MD, PhD
Shalvata Medical Health Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2012
First Posted
April 10, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
July 4, 2012
Record last verified: 2012-04