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

Primary Purpose

Unipolar Depression

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Minocycline

About this trial

This is an interventional treatment trial for Unipolar Depression

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
-

Exclusion Criteria:

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.
-

Sites / Locations

Shalvata Medical Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minocycline

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Depression symptoms - CGI

The change in Clinical Global Impression Scale (CGI) from baseline to the end of the study.

depression symptoms - (QIDS-SR)

The change in Quick Inventory of Depressive Symptology -self report (QIDS-SR) from baseline to the end of the study.

depression symptoms - HDRS-21

Remission rates after 5 weeks of Minocycline treatment, where remission is defined as HDRS-21 score <10.

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).

Full Information

NCT ID

NCT01574742

First Posted

April 9, 2012

Last Updated

July 3, 2012

Sponsor

Shalvata Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT01574742

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shalvata Mental Health Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unipolar Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Minocycline

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Minocycline

Other Intervention Name(s)

Minoclin

Intervention Description

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)

Primary Outcome Measure Information:

Title

Depression symptoms

Description

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)

Secondary Outcome Measure Information:

Title

Depression symptoms - CGI

Description

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)

Title

depression symptoms - (QIDS-SR)

Description

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)

Title

depression symptoms - HDRS-21

Description

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)

Title

Safety

Description

Time Frame

frpm baseline (day 1) untill the termination visit (day 35)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. - Exclusion Criteria: 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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

yechiel levkovitz, MD, PhD

Phone

00-972-9-7478644

ylevk@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Nurit Sternberg

nuritstern@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yechiel Levkovitz, MD, PhD

Organizational Affiliation

Shalvata Medical Health Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shalvata Medical Health Center

City

Hod-HaSharon

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yechiel Levkovitz, MD, PhD

Phone

00-972-9-7478644

ylevk@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Yechiel Levkovitz, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

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

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