Major Depressive DisorderPhase 2Mino-TRDNCT02456948
Adjunct Minocyline in Treatment-resistant Depression
A Phase 2 study testing Minocycline in people with Major Depressive Disorder, run by Charite University, Berlin, Germany at 9 sites in Germany.
Trial summary
This study examines the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Minocycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 9 sitesGermany
- Study dates
- Jan 2015to 7 Aug 2020
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- male or female
- between age 18 and 75
- BMI between 18 and 40 inclusive
- Non-lactating, non-pregnant females of child-bearing potential must be willing to use an effective contraceptive method
- All participants must fulfil diagnostic criteria of moderate or severe MDD according to the DSM-5.
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- HAMD-17 score of at least 16 points at baseline and a
- CGI-S score of at least 4.
- AD-ST must have been administered at a sufficient dose for at least 6 weeks in the current episode and at a
- stable regimen for at least 14 days prior to baseline.
- Dose and duration of AD-ST must be verifiable
Who cannot join
- prevalence of neurodegenerative disorder
- prevalence of any neurological disorder that caused the depressive symptoms
- prevalence of any severe, unstable general medical condition, including chronic inflammatory disease such as rheumatoid arthritis or inflammatory bowel disease
- prevalence of any other psychiatric disorder that better explains the presence of depressive symptoms
- Improvement by more than 50% in HAMD-17 score during the last 14 days prior to baseline
- pregnant or nursing women will not be allowed.
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- substance or alcohol abuse within past 6 months or positive urine drug screening
- abnormal thyroid function (euthyroid at presentation), liver or kidney dysfunction
- history of autoimmune disease (except Hashimotos thyroiditis)
- clinically significant laboratory abnormalities (outside normal ranges)
- current medication with anti-inflammatory substances (NSAIDs, corticosteroids)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital RWTH Aachen
Aachen
Department of Psychiatry, Charité - Campus Benjamin Franklin
Berlin, 12203
Department of Psychiatry, Universitiy Hospital
Erlangen, Bavaria, 91054
Dept. of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt
Frankfurt
Department of Psychiatry, University Medical Center Göttingen
Göttingen, Lower Saxony, 37075
Heidelberg University Hospital, Department of Psychiatry
Heidelberg, Baden-Wurttemberg, 69115
Department of Psychiatry, LMU Munich
Munich, Bavaria, 80336
Max Planck Institute of Psychiatry
Munich, Bavaria, 80804
Department of Psychiatry, Universitiy Hospital
Regensburg, Bavaria, 93053
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Unipolar Major Depressive Disorder (MDD)
This study examines the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD).
Read the detailed description
This is a double-blind, placebo-controlled, randomized, multicenter proof-of-principle trial of adjunctive minocycline for patients with unipolar major depressive disorder (MDD). The study tests the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD). The respective AD, for which non-response has been documented, must be on a stable regimen for at least 14 days prior to inclusion. AD-ST will then be continued throughout the trial. Trial medication is adjunct oral minocycline 200 mg/day or placebo. Response to treatment will be measured via the Montgomery-Asberg Depression Rating Scale (MADRS). The total study duration for each patient will be 6 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- Minocycline, Placebo
- Keywords
- treatment resistant depression, inflammation, microglia, minocycline
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Inflammation, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Solodyn, Minocin
6 weeks 200mg/day Minocycline add-on
PlaceboDrug
Also called Sugar pills, mimics Minocycline tablet
6 weeks Placebo add-on
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Minocycline and standard antidepressant treatment Receives: Drug: Minocycline |
| Placebo | Placebo comparator | Placebo and standard antidepressant treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)
Measured: 6 weeks
Secondary outcomes (7)
Remission as per MADRS (Montgomery-Åsberg Depression Rating Scale)
Measured: 6 weeks
HAM-D-17-Scale (17-item Hamilton Depression Rating Scale)
Measured: 6 weeks
BDI-Scale (Beck Depression Inventory, Self Rating Scale)
Measured: 6 weeks
CGI-Scale (Clinical Global Impressions Scale)
Measured: 6 weeks
SCL-90-R (Symptom Checklist 90-R, Self Rating Scale)
Measured: 6 weeks
Transcriptomic changes in patient-specific peripheral blood-derived monocytic cells
Measured: 6 weeks
Protein levels of various inflammation-associated markers in patient sera
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJan 2015
- Primary completion7 Aug 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabella Heuser, Charite University, Berlin, Germany
- Investigators
- Isabella Heuser, MD, PhD, Principal investigator, Chair: Department of Psychiatry Charité - Campus Benjamn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456948
- Sponsor's protocol ID
- 01EE1401F
- Acronym
- Mino-TRD
- Status last verified
- Oct 2020
- First submitted
- 27 May 2015
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Unipolar Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT02456948
- Acronym / sponsor ID
- Mino-TRD / 01EE1401F
- Conditions
- Major Depressive Disorder
- Keywords
- treatment resistant depression, inflammation, microglia, minocycline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 29 May 2015 (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.
This study examines the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD).
Detailed description
This is a double-blind, placebo-controlled, randomized, multicenter proof-of-principle trial of adjunctive minocycline for patients with unipolar major depressive disorder (MDD). The study tests the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD). The respective AD, for which non-response has been documented, must be on a stable regimen for at least 14 days prior to inclusion. AD-ST will then be continued throughout the trial. Trial medication is adjunct oral minocycline 200 mg/day or placebo. Response to treatment will be measured via the Montgomery-Asberg Depression Rating Scale (MADRS). The total study duration for each patient will be 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: MinocyclineMinocycline and standard antidepressant treatment |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo and standard antidepressant treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed consent
- male or female
- between age 18 and 75
- BMI between 18 and 40 inclusive
- Non-lactating, non-pregnant females of child-bearing potential must be willing to use an effective contraceptive method
Key exclusion criteria (11 listed)
- prevalence of neurodegenerative disorder
- prevalence of any neurological disorder that caused the depressive symptoms
- prevalence of any severe, unstable general medical condition, including chronic inflammatory disease such as rheumatoid arthritis or inflammatory bowel disease
- prevalence of any other psychiatric disorder that better explains the presence of depressive symptoms
- Improvement by more than 50% in HAMD-17 score during the last 14 days prior to baseline
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: Solodyn, Minocin6 weeks 200mg/day Minocycline add-on | Drug | Minocycline |
| PlaceboAlso: Sugar pills, mimics Minocycline tablet6 weeks Placebo add-on | Drug | Placebo |
Primary outcome
Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)
Time frame: 6 weeks
7 secondary outcomes
Remission as per MADRS (Montgomery-Åsberg Depression Rating Scale)
Time frame: 6 weeks
HAM-D-17-Scale (17-item Hamilton Depression Rating Scale)
Time frame: 6 weeks
BDI-Scale (Beck Depression Inventory, Self Rating Scale)
Time frame: 6 weeks
CGI-Scale (Clinical Global Impressions Scale)
Time frame: 6 weeks
SCL-90-R (Symptom Checklist 90-R, Self Rating Scale)
Time frame: 6 weeks
Transcriptomic changes in patient-specific peripheral blood-derived monocytic cells
Time frame: 6 weeks
Protein levels of various inflammation-associated markers in patient sera
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Isabella Heuser, MD, PhD principal investigator
Chair: Department of Psychiatry Charité - Campus Benjamn
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline in people with Major Depressive Disorder, run by Charite University, Berlin, Germany at 9 sites in Germany.
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 11 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: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response as per MADRS (Montgomery-Åsberg Depression Rating Scale) (time frame: 6 weeks). 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 19 Oct 2020.