First Episode Psychosis Clinical Trial
Official title:
A Randomised, Double Blind Pilot Study of Minocycline and Placebo Added to Treatment-as-Usual (TAU) in First-Episode Psychosis
The purpose of this study is to determine whether the addition of minocycline or placebo to
treatment as usual (TAU):
1. prevents the accumulation of negative symptoms and intellectual decline following a
first episode of non-affective psychosis; and
2. whether minocycline stabilizes the efficacy of antipsychotics.
Status | Completed |
Enrollment | 52 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Aged 18 to 65 years - Diagnostic and Statistical Manual-IV (DSM-IV) diagnosed first episode psychosis, schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder - First episode (within first 5 years of diagnosis) - Competent and willing to give informed consent - Medication remained stable 4 weeks prior to baseline - Able to take oral medication and likely to complete the required evaluations - Female participants of child bearing capability must be willing to use adequate contraceptives for the duration of the study, and, willing to have a pregnancy test pre-treatment and at ten weekly intervals while on study medication Exclusion Criteria: - Relevant medical illness [renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosus (SLE)] in the opinion of the investigators (see section 6.2a) - Prior history of intolerance to any of the tetracyclines - Concomitant penicillin therapy - Concomitant anticoagulant therapy - Presence of a seizure disorder, not including clozapine-induced seizures - Presently taking valproic acid - Any change of psychotropic medications within the previous six weeks - Diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-IV criteria - Pregnant or breast-feeding |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Department of Neurology, Psychiatry and Psychological Medicine, University of San Paulo | San Paulo | |
Pakistan | Civil Hospital Karachi | Karachi | |
Pakistan | Karwan e Hayat | Karachi | |
Pakistan | Institute of Psychiatry, Rawalpindi medical College | Rawalpindi |
Lead Sponsor | Collaborator |
---|---|
Stanley Medical Research Institute | Pakistan Institute of Learning and Living, Rawalpindi Medical College, Pakistan, University of Sao Paulo |
Brazil, Pakistan,
Chen M, Ona VO, Li M, Ferrante RJ, Fink KB, Zhu S, Bian J, Guo L, Farrell LA, Hersch SM, Hobbs W, Vonsattel JP, Cha JH, Friedlander RM. Minocycline inhibits caspase-1 and caspase-3 expression and delays mortality in a transgenic mouse model of Huntington disease. Nat Med. 2000 Jul;6(7):797-801. — View Citation
Denovan-Wright EM, Devarajan S, Dursun SM, Robertson HA. Maintained improvement with minocycline of a patient with advanced Huntington's disease. J Psychopharmacol. 2002 Dec;16(4):393-4. — View Citation
Gabrovska-Johnson VS, Scott M, Jeffries S, Thacker N, Baldwin RC, Burns A, Lewis SW, Deakin JF. Right-hemisphere encephalopathy in elderly subjects with schizophrenia: evidence from neuropsychological and brain imaging studies. Psychopharmacology (Berl). 2003 Sep;169(3-4):367-75. Epub 2003 Jul 4. — View Citation
Stirling J, White C, Lewis S, Hopkins R, Tantam D, Huddy A, Montague L. Neurocognitive function and outcome in first-episode schizophrenia: a 10-year follow-up of an epidemiological cohort. Schizophr Res. 2003 Dec 15;65(2-3):75-86. — View Citation
Yrjänheikki J, Tikka T, Keinänen R, Goldsteins G, Chan PH, Koistinaho J. A tetracycline derivative, minocycline, reduces inflammation and protects against focal cerebral ischemia with a wide therapeutic window. Proc Natl Acad Sci U S A. 1999 Nov 9;96(23):13496-500. — View Citation
Zhu S, Stavrovskaya IG, Drozda M, Kim BY, Ona V, Li M, Sarang S, Liu AS, Hartley DM, Wu DC, Gullans S, Ferrante RJ, Przedborski S, Kristal BS, Friedlander RM. Minocycline inhibits cytochrome c release and delays progression of amyotrophic lateral sclerosis in mice. Nature. 2002 May 2;417(6884):74-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive and negative symptoms on Positive and Negative Syndrome Scale (PANSS) | Baseline and 12 months | No | |
Secondary | Clinical Global Impression (CGI) | Baseline and 12 months | No | |
Secondary | Global Assessment of Functioning (GAF) | Baseline and 12 months | No | |
Secondary | Abnormal Involuntary Movement Scale (AIMS) | Baseline and 12 months | No | |
Secondary | Assessment of side effects | Baseline and 12 months | No | |
Secondary | Doses of antipsychotic drugs | Baseline and 12 months | No | |
Secondary | neurocognitive test scores | Baseline and 12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
Completed |
NCT00202280 -
Efficacy of Treating First Episode Psychosis With Folic Acid,B12 and B6 in Addition to Antipsychotic Medication
|
Phase 2/Phase 3 | |
Completed |
NCT01026584 -
Efficacy and Safety of Aripiprazole in First Episode Psychosis
|
Phase 4 | |
Completed |
NCT03983421 -
Feasibility of an Early Detection Program for Early Psychosis on a College Campus
|
||
Recruiting |
NCT04046497 -
Artificial Intelligence to Measure Adherence to Oral Medication
|
Phase 4 | |
Withdrawn |
NCT04369677 -
Thermoregulation Among Individuals With First-episode Psychosis
|
||
Completed |
NCT03568500 -
A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic
|
Phase 4 | |
Completed |
NCT03102151 -
Reducing the Duration of Untreated Psychosis
|
||
Recruiting |
NCT05310838 -
Optimizing Engagement in Services for First-Episode Psychosis
|
N/A | |
Completed |
NCT03501160 -
Socially Inappropriate Behaviour in People With First Episode Psychosis: A Caregivers' Perspective
|
||
Recruiting |
NCT03196128 -
Early Intervention Psychosis Communication and Engagement Trial
|
N/A | |
Recruiting |
NCT04005378 -
Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs
|
Phase 4 | |
Recruiting |
NCT03919760 -
Early Psychosis Intervention - Spreading Evidence-based Treatment
|
||
Completed |
NCT03409393 -
Feasibility and Relevance of High-Intensity Functional Training in Patients With First-Episode Psychosis
|
N/A | |
Completed |
NCT01753284 -
First Episode Psychosis and Pathway to Care in Nordland
|
||
Completed |
NCT01157585 -
Efficacy and Safety of Paliperidone ER in First Episode Psychosis
|
Phase 4 | |
Completed |
NCT05737966 -
Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist
|
||
Recruiting |
NCT04021719 -
OnTrackNY's Learning Healthcare System
|
||
Recruiting |
NCT04889911 -
Pilot RCT of Self-stigma Treatment for First Episode Psychosis
|
N/A | |
Recruiting |
NCT04853485 -
Repetitive Transcranial Magnetic Stimulation in Early Psychosis and The Functional Connectivity Biotypes
|
N/A |