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Open Study Assessing the Feasibility of Minocycline in Patients With Unipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574742
Recruitment Status : Unknown
Verified April 2012 by Shalvata Mental Health Center.
Recruitment status was:  Recruiting
First Posted : April 10, 2012
Last Update Posted : July 4, 2012
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center

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.


Condition or disease Intervention/treatment Phase
Unipolar Depression Drug: Minocycline Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Open Label Study Assessing the Feasibility, Safety and Therapeutic Effect of Minocycline in Adult Patients With Diagnosis of Unipolar Depression.
Study Start Date : June 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minocycline
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)
Drug: Minocycline
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)
Other Name: Minoclin




Primary Outcome Measures :
  1. Depression symptoms [ Time Frame: from baseline (day 1) to termination (day 35) ]
    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.


Secondary Outcome Measures :
  1. Depression symptoms - CGI [ Time Frame: from baseline (day 1) untill termination visit (day 35) ]
    The change in Clinical Global Impression Scale (CGI) from baseline to the end of the study.

  2. depression symptoms - (QIDS-SR) [ Time Frame: from baseline (day 1) untill termination visit (day 35) ]
    The change in Quick Inventory of Depressive Symptology -self report (QIDS-SR) from baseline to the end of the study.

  3. depression symptoms - HDRS-21 [ Time Frame: from baseline (day 1) untill termination visit (day 35) ]
    Remission rates after 5 weeks of Minocycline treatment, where remission is defined as HDRS-21 score <10.

  4. Safety [ Time Frame: frpm baseline (day 1) untill the termination visit (day 35) ]

    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients and inpatients
  2. Men and women 18-68 years of age.
  3. 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.
  4. Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit.
  5. The patient did not respond to at least one antidepressant medication given for an accepted dose and duration.
  6. Capable and willing to provide informed consent
  7. Able to adhere to the treatment schedule.

    -

Exclusion Criteria:

  1. Depression secondary to a general medical condition.
  2. History of substance abuse or dependence within the past 6 month (except opioids, nicotine and caffeine).
  3. 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.
  4. Use of any medication(s) listed on the Excluded medication list within the time that mansion for each medication on the list.
  5. Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • Bipolar disorder • Eating disorder
  6. Subjects who were taking a known contraindication to minocycline treatment.
  7. Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
  8. 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
  9. 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
  10. Patients with severe hepatic or renal insufficiency.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574742


Contacts
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Contact: yechiel levkovitz, MD, PhD 00-972-9-7478644 ylevk@clalit.org.il
Contact: Nurit Sternberg nuritstern@gmail.com

Locations
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Israel
Shalvata Medical Health Center Recruiting
Hod-HaSharon, Israel
Contact: Yechiel Levkovitz, MD, PhD    00-972-9-7478644    ylevk@clalit.org.il   
Principal Investigator: Yechiel Levkovitz, MD,PhD         
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
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Principal Investigator: Yechiel Levkovitz, MD, PhD Shalvata Medical Health Center
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Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01574742    
Other Study ID Numbers: 0007-12-SHA
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents