Unipolar DepressionPhase 1NCT01574742
Open Study Assessing the Feasibility of Minocycline in Patients With Unipolar Depression
A Phase 1 study testing Minocycline in people with Unipolar Depression, run by Shalvata Mental Health Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Minocycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
Show all 11Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Nurit Sternberg contact
Israel1 site, 1 recruiting
- Recruiting
Shalvata Medical Health Center
Hod HaSharon
Yechiel Levkovitz, MD, PhD, 00-972-9-7478644, ylevk@clalit.org.il
Yechiel Levkovitz, MD,PhD
About this study
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.
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.
- Conditions
- Unipolar Depression
- Being tested
- Minocycline
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Minoclin
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)
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | 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) Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline (day 1) to termination (day 35)
Secondary outcomes (4)
Depression symptoms - CGI
The change in Clinical Global Impression Scale (CGI) from baseline to the end of the study.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: frpm baseline (day 1) untill the termination visit (day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yechiel Levkovitz, MD, PhD, Principal investigator, Shalvata Medical Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574742
- Sponsor's protocol ID
- 0007-12-SHA
- Status last verified
- Apr 2012
- First submitted
- 9 Apr 2012
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01574742
- Acronym / sponsor ID
- 0007-12-SHA
- Conditions
- Unipolar Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: MinocyclineMinocycline 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) |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineAlso: MinoclinMinocycline 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 |
Primary outcome
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.
4 secondary outcomes
Depression symptoms - CGI
Time frame: from baseline (day 1) untill termination visit (day 35)
depression symptoms - (QIDS-SR)
Time frame: from baseline (day 1) untill termination visit (day 35)
depression symptoms - HDRS-21
Time frame: from baseline (day 1) untill termination visit (day 35)
Safety
Time frame: frpm baseline (day 1) untill the termination visit (day 35)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurit Sternberg contact
Yechiel Levkovitz, MD, PhD principal investigator
Shalvata Medical Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minocycline in people with Unipolar Depression, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yechiel levkovitz, MD, PhD (00-972-9-7478644, ylevk@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms (time frame: from baseline (day 1) to termination (day 35)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2012.