Minocycline Augmentation in Schizophrenia

NCT01561742 | Unknown DMC

• 1 other identifier: HSC-MS-11-0201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the efficacy of minocycline augmentation in a sample of moderately ill outpatients with early-course schizophrenia on their chlorpromazine-equivalent doses of second-generation antipsychotic medications. The investigators hypothesize that as compared to placebo a 2-month treatment with minocycline in 120 volunteers with early-course schizophrenia will result in a more significant improvement in psychopathology (primary outcome) and cognitive symptoms (secondary outcome). In addition, cytokine plasma levels will be used as another secondary outcome measure to see if treatment-induced changes in total PANSS score are associated with changes in cytokine levels.

Conditions

Schizophrenia

Keywords

minocycline, augmentation, schizophrenia

Outcome Measures

Primary Outcomes (1)

• Treatment-induced change in total score on Positive and Negative Syndrome Scale (PANSS)

  PANSS total score will be used to examine treatment-induced change in psychaopthology. The PANSS is a 30-item rating scale used to assess symptoms of psychopathology. We will use the total PANSS score as the primary outcome measure which reflects total level of psychopathology including the positive and negative symptoms as well as general psychopathology.This measure will be administered at baseline, week 8 and week 16 of the study to assess if minocyline treatment results in a significant reduction in PANSS total score as opposed to placebo.

  Baseline, week 8, and week 16 of the study

Secondary Outcomes (2)

• Treatment-induced change in MATRICS Cognitive Consensus Battery (MCCB)

  Baseline and week 16 of the study

• Treatment-induced changes in plasma level of cytokines

  Baseline and week 16 of the study

Study Arms (2)

Minocycline

EXPERIMENTAL

Drug: Minocycline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Minocycline DRUG

Minocycline will be given orally at 200 mg a day for 4 months

Also known as: Minocin

Minocycline

Placebo DRUG

EquivalentPlacebo will be given

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages between 18-35 years
• Males \& females
• Current DSM-IV diagnosis of schizophrenia or schizoaffective disorder confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) conducted by a trained psychiatrist.
• Treatment with a stable dose of second generation antipsychotic medication for at least 1 months prior to study entry 200-600 mg/day chlorpromazine equivalent doses);
• Evidence of stable symptomatology for 12 weeks as evidenced by no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms, no ER use for symptoms of schizophrenia and no significant changes to antipsychotic medication or dose (\>25%) in the past 12 weeks.
• Baseline total score between 40 and 65 on the Brief Psychiatric Rating Scale (BPRS);
• Raw score of 12 or higher on the Wechsler Test of Adult Reading (WTAR) (estimates premorbid IQ).
• Able to comprehend the procedure and aims of the study to provide informed consent

You may not qualify if:

• Acute, unstable, significant or untreated medical illness beside schizophrenia;
• Pregnant or breast-feeding females;
• History of substance abuse or dependence in the past 3 months.
• Known contraindication to minocycline treatment.
• Treatment with minocycline or Beta-lactam antibiotics in the preceding half year before study entry.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Harris County Psychiatric Center

Houston, Texas, 77021, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Mujeeb U Shad, MD, MSCS

  UT Health Sciences Center at Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna E Gerwer, BS

CONTACT

7134862574; johanna.e.gerwer@uth.tmc.edu

Wilmer J Burns, MS

CONTACT

7134862574; wilmer.j.burns@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 23, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 23, 2012

Record last verified: 2012-03

Locations

US (1)