Recruiting

Minocycline

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT01561742

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Minocycline

Placebo

Study Details

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

Study ID

NCT01561742

Start date

Feb, 2012

Status verified date

Mar, 2012

Completion date

Jan, 2015

Anticipated

Primary completion date

Jan, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Ages between 18-35 years
2. Males \& females
3. 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.
4. 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);
5. 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.
6. Baseline total score between 40 and 65 on the Brief Psychiatric Rating Scale (BPRS);
7. Raw score of 12 or higher on the Wechsler Test of Adult Reading (WTAR) (estimates premorbid IQ).
8. Able to comprehend the procedure and aims of the study to provide informed consent

Exclusion Criteria:

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Minocycline

placebo comparator: Placebo

Interventions

Minocycline

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

Placebo

EquivalentPlacebo will be given

Primary outcome measure

  • Treatment-induced change in total score on Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, week 8, and week 16 of the study ]

Central Contacts and Locations

Central contacts

Locations

Harris County Psychiatric Center

Recruiting

Houston, Texas, United States, 77021

Contacts

Principal Investigator:

Mujeeb U Shad, M.D.

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Mar 23, 2012

Last verified

Mar, 2012

Keywords

  • minocycline, augmentation, schizophrenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2012-03-23.