SchizophreniaPhase 4NCT01493622
The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia
A Phase 4 study testing minocycline in people with Schizophrenia, run by Central South University at 1 site in China.
Trial summary
The purpose of this study is to determine whether minocycline are effective in the treatment of negative and cognitive symptoms in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Dec 2011
- Phase
- Phase 4
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female,were aged 18-40 years
- were currently diagnosed with DSM-IV schizophrenia
- were able to comprehend the cognition test
- patients or guardian signed informed consent,were able to comprehend the procedure and aims of the study,agreed to join the study
- patient's current antipsychotic medication regimen must be stable
- must be in a stable living arrangement
Who cannot join
- had ever been hypersensitivity to minocycline or tetracycline;
- had acute,unstable,significant,or untreated medical illness besides schizophrenia
- were pregnant or breast-feeding;
- had a DSM-IV diagnosis of substance abuse or dependency;
- had a tendency to suicide or Violence,self-harm;
- had taken immunosuppressive agents in the preceding 3 months before study entry;
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- had influenza or fever in the preceding 2 weeks before study entry;
- had a DSM-IV diagnosis of emotional psychosis,Mental retardation,etc.
- has suicidal attempts or ideation or violent behavior within the last 12 months
- patient has mental retardation or severe organic brain syndromes
- treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychiatry, The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, 650031
About this study
Official title: A Double-Blind,Randomized Study of Minocycline for the Treatment of Negative and Cognitive Symptoms in Schizophrenia
The purpose of this study is to determine whether minocycline are effective in the treatment of negative and cognitive symptoms in schizophrenia.
Read the detailed description
Immune-related disorders have been hypothesized as etiological factors in schizophrenia.Minocycline is a second-generation tetracycline that exerts anti-inflammatory and antimicrobial effects while having a distinct neuroprotective profile.This study was performed as a double-blind, placebocontrolled,randomized evaluation of Second generation antipsychotics(SGA) and minocycline versus SGA and placebo.
- Conditions
- Schizophrenia
- Being tested
- minocycline, placebo
- Keywords
- Schizophrenia minocycline cognition
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minocyclineDrug
Also called Minocycline Hydrochloride Capsules
variable dose SGA and minocycline,100mg per capsule po（take orally） bid，16 weeks；
placeboDrug
variable dose SGA and 100mg per capsule po（take orally） bid，16 weeks；
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Subjects will be given with 200mg/day placebo(100mg,bid) and variable dose SGA. All drugs will be administered orally. Receives: Drug: placebo |
| minocycline | Active comparator | Subjects will be given with 200mg/day minocycline (100mg,bid)and variable dose SGA.All drugs will be administered orally. Receives: Drug: minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in the Composite Score From the Cognition Assessment Battery and SANS Total Scores After 16 Weeks of Treatment
The Cognitive Assessment Battery included Making Test (TMT) ,Symbol Coding,Hopkins Verbal Learning Test-Revised ,Mazes,Brief Visuospatial Memory Test-Revised ,Continuous Performance Test-Identical Pairs,Grooved Pegboard Test,Color Trail Test,Stroop Task,Verbal Fluency,Paced Auditory Serial Addition Test and Wisconsin Card Sorting Test SANS=Scale for the Assessment of Negative Symptoms
Measured: 16 weeks
Secondary outcomes (3)
Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment
Measured: 16 weeks
Cytokine Measure
Cytokine Measure:IL-1β,IL-6,TNF-α,Nitric Oxide (NO)、S100B
Measured: 16 weeks
metabolic index
weight,height,insulin and waist circumference,
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Liu, Central South University
- Investigators
- Zhao J Ping, Principal investigator, The Second Xiangya Hospital, Central South University,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493622
- Sponsor's protocol ID
- CSU-2010-PSY
- Other IDs
- 2010LL02
- Status last verified
- Dec 2011
- First submitted
- 20 Dec 2010
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levkovitz Y, Mendlovich S, Riwkes S, Braw Y, Levkovitch-Verbin H, Gal G, Fennig S, Treves I, Kron S. A double-blind, randomized study of minocycline for the treatment of negative and cognitive symptoms in early-phase schizophrenia. J Clin Psychiatry. 2010 Feb;71(2):138-49. doi: 10.4088/JCP.08m04666yel. Epub 2009 Nov 3.
PubMed 19895780Liu F, Zhang B, Xie L, Ruan Y, Xu X, Zeng Y, Messina L, Zhao J, Fan X. Changes in plasma levels of nitric oxide metabolites and negative symptoms after 16-week minocycline treatment in patients with schizophrenia. Schizophr Res. 2018 Sep;199:390-394. doi: 10.1016/j.schres.2018.03.003. Epub 2018 Mar 9.
PubMed 29526457Liu F, Guo X, Wu R, Ou J, Zheng Y, Zhang B, Xie L, Zhang L, Yang L, Yang S, Yang J, Ruan Y, Zeng Y, Xu X, Zhao J. Minocycline supplementation for treatment of negative symptoms in early-phase schizophrenia: a double blind, randomized, controlled trial. Schizophr Res. 2014 Mar;153(1-3):169-76. doi: 10.1016/j.schres.2014.01.011. Epub 2014 Feb 3.
PubMed 24503176
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind,Randomized Study of Minocycline for the Treatment of Negative and Cognitive Symptoms in Schizophrenia
- ClinicalTrials.gov ID
- NCT01493622
- Acronym / sponsor ID
- CSU-2010-PSY
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia minocycline cognition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Dec 2011 (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.
The purpose of this study is to determine whether minocycline are effective in the treatment of negative and cognitive symptoms in schizophrenia.
Detailed description
Immune-related disorders have been hypothesized as etiological factors in schizophrenia.Minocycline is a second-generation tetracycline that exerts anti-inflammatory and antimicrobial effects while having a distinct neuroprotective profile.This study was performed as a double-blind, placebocontrolled,randomized evaluation of Second generation antipsychotics(SGA) and minocycline versus SGA and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboSubjects will be given with 200mg/day placebo(100mg,bid) and variable dose SGA. All drugs will be administered orally. |
| minocycline | Active comparator | Drug: minocyclineSubjects will be given with 200mg/day minocycline (100mg,bid)and variable dose SGA.All drugs will be administered orally. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male and female,were aged 18-40 years
- were currently diagnosed with DSM-IV schizophrenia
- were able to comprehend the cognition test
- patients or guardian signed informed consent,were able to comprehend the procedure and aims of the study,agreed to join the study
- patient's current antipsychotic medication regimen must be stable
Key exclusion criteria (11 listed)
- had ever been hypersensitivity to minocycline or tetracycline;
- had acute,unstable,significant,or untreated medical illness besides schizophrenia
- were pregnant or breast-feeding;
- had a DSM-IV diagnosis of substance abuse or dependency;
- had a tendency to suicide or Violence,self-harm;
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: Minocycline Hydrochloride Capsulesvariable dose SGA and minocycline,100mg per capsule po（take orally） bid，16 weeks； | Drug | minocycline |
| placebovariable dose SGA and 100mg per capsule po（take orally） bid，16 weeks； | Drug | placebo |
Primary outcome
Mean Change from Baseline in the Composite Score From the Cognition Assessment Battery and SANS Total Scores After 16 Weeks of Treatment
Time frame: 16 weeks
The Cognitive Assessment Battery included Making Test (TMT) ,Symbol Coding,Hopkins Verbal Learning Test-Revised ,Mazes,Brief Visuospatial Memory Test-Revised ,Continuous Performance Test-Identical Pairs,Grooved Pegboard Test,Color Trail Test,Stroop Task,Verbal Fluency,Paced Auditory Serial Addition Test and Wisconsin Card Sorting Test SANS=Scale for the Assessment of Negative Symptoms
3 secondary outcomes
Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment
Time frame: 16 weeks
Cytokine Measure
Time frame: 16 weeks
metabolic index
Time frame: 16 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 16 Dec 2011.
- Results publication: PubMed 19895780Levkovitz Y, Mendlovich S, Riwkes S, Braw Y, Levkovitch-Verbin H, Gal G, Fennig S, Treves I, Kron S. A double-blind, randomized study of minocycline for the treatment of negative and cognitive symptoms in early-phase schizophrenia. J Clin Psychiatry. 2010 Feb;71(2):138-49. doi: 10.4088/JCP.08m04666yel. Epub 2009 Nov 3.
- Derived from this study: PubMed 29526457Liu F, Zhang B, Xie L, Ruan Y, Xu X, Zeng Y, Messina L, Zhao J, Fan X. Changes in plasma levels of nitric oxide metabolites and negative symptoms after 16-week minocycline treatment in patients with schizophrenia. Schizophr Res. 2018 Sep;199:390-394. doi: 10.1016/j.schres.2018.03.003. Epub 2018 Mar 9.
- Derived from this study: PubMed 24503176Liu F, Guo X, Wu R, Ou J, Zheng Y, Zhang B, Xie L, Zhang L, Yang L, Yang S, Yang J, Ruan Y, Zeng Y, Xu X, Zhao J. Minocycline supplementation for treatment of negative symptoms in early-phase schizophrenia: a double blind, randomized, controlled trial. Schizophr Res. 2014 Mar;153(1-3):169-76. doi: 10.1016/j.schres.2014.01.011. Epub 2014 Feb 3.
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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.
Zhao J Ping principal investigator
The Second Xiangya Hospital, Central South University,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing minocycline in people with Schizophrenia, run by Central South University at 1 site in China.
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 6 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 16 Dec 2011. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean Change from Baseline in the Composite Score From the Cognition Assessment Battery and SANS Total Scores After 16 Weeks of Treatment (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01493622, which also lists 3 linked publications.
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 16 Dec 2011.