NCT00733057

Brief Summary

Current antipsychotics have only a limited effect on two core symptoms of schizophrenia, negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline which has a beneficial effect in various neurological disorders. Recent findings in animal models and human case-reports suggest its potential for the treatment of these symptoms of schizophrenia. The current study aims to examine the efficacy of minocycline as add-on treatment for alleviating negative and cognitive symptoms in early-phase schizophrenia. The study will utilize a longitudinal double blind, randomized, placebo-controlled design with patients followed for six-months. Early-phase schizophrenia patients were recruited and randomly allocated to a minocycline or placebo treatment (2:1 ratio; 200 mg/day). The primary outcome measures are the Scale for Assessment of Negative Symptoms (SANS) and assessments of executive functions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
Last Updated

August 12, 2008

Status Verified

August 1, 2008

Enrollment Period

3.6 years

First QC Date

August 11, 2008

Last Update Submit

August 11, 2008

Conditions

Negative and Cognitive Symptoms in Schizophrenia

Keywords

MinocyclineSchizophreniaNegative symptomsCognitive

Outcome Measures

Primary Outcomes (1)

  • Scale for Assessment of Negative Symptoms (SANS)

    Change in SANS scores over the 6-month study

Secondary Outcomes (1)

  • PANSS, CGI, CDS, ITAQ, CANTAB measures, adverse events.

    Change during the 6-month duration of the study

Study Arms (2)

1

EXPERIMENTAL

Minocycline treatment

Drug: Minocycline

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo (200 mg/day)

Interventions

MinocyclineDRUG

Minocycline as an add-on drug (200 mg/day)

1
Placebo (200 mg/day)DRUG
2

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18-35 years;
  • current DSM-IV diagnosis of schizophrenia confirmed by the Structured Clinical Interview for DSM-IV (SCID) conducted by a trained psychiatrist.
  • being at an early phase of the disorder (i.e., within five years of their first exposure to neuroleptic treatment;18)
  • did not receive antipsychotic treatment for six months preceding current symptom exacerbation;
  • baseline total score of more than 60 on the Positive and Negative Syndrome Scale (PANSS).
  • Initiation of treatment with atypical antipsychotic medication equal or less than 14 days prior to study entry (risperidone, olanzapine, quetiapine, or clozapine; 200-600 mg/day chlorpromazine equivalent doses);
  • able to comprehend the procedure and aims of the study.

You may not qualify if:

  • acute, unstable, significant or untreated medical illness beside schizophrenia;
  • pregnant or breast-feeding females;
  • A DSM-IV diagnosis of substance abuse or dependency;
  • Known contraindication to minocycline treatment.
  • Treatment with minocycline or Beta-lactam antibiotics in the preceding half year before study entry.
  • Under compulsory hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Emotion-Cognition Research Center, The Shalvata Mental Health Care Center, P.O.B. 94.

Hod HaSharon, 70300, Israel

Location

Related Publications (1)

  • 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.

    PMID: 19895780DERIVED

Related Links

MeSH Terms

Conditions

cyclopia sequenceSchizophrenia

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Yechiel - Levkovitz, M.D. PhD.

    Shalvata Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 12, 2008

Study Start

August 1, 2003

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

August 12, 2008

Record last verified: 2008-08

Locations

IL(1)