Minocycline for Schizophrenia

NCT01809158 | Completed Phase 4 DMC

• 1 other identifier: 11T-013
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom dimensions. The negative symptom dimension, with its protean cognitive manifestations, responds poorly to treatment, which can be a particular challenge in countries where clozapine therapy is not available. Preliminary data indicates that minocycline may be beneficial adjunct in the treatment of schizophrenia: positive, negative, and cognitive symptoms. Persons with schizophrenia or schizoaffective disorder and recent onset schizophrenic episode or recent relapse who are prescribed minocycline in addition to standard antipsychotic medication will show greater symptom reduction, as measured by the Positive and Negative Syndrome Scale (PANSS) total score.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change in Positive and Negative Syndrome Scale (PANSS) total score

  Change in symptom severity from baseline to Week 12, as measured by the change in PANSS total score, compared between the treatment arms (minocycline vs. placebo)

  baseline, week 12

Study Arms (2)

minocycline

ACTIVE COMPARATOR

Subjects randomized to the minocycline group will take 2 tablets per day, each 100mg of minocycline, for a total daily dose of 200mg of minocycline.

Drug: minocycline

placebo

PLACEBO COMPARATOR

Subjects randomized to the placebo group will take 2 tablets of placebo (matched for minocycline) per day.

Drug: placebo

Interventions

minocycline DRUG

minocycline

placebo DRUG

placebo

Eligibility Criteria

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

You may qualify if:

• Age 18-64 years
• Primary Axis I diagnosis (DSM-IV) of schizophrenia, any subtype
• The current episode should be either a relapse episode or a first onset schizophrenia and the duration of the relapse episode and first onset schizophrenia should be under five years
• Indication of treatment-resistance defined by failure of at least on adequate dose of antipsychotic medication (equivalent to chlorpromazine of 200 mg/day or more) given for at least four weeks. For the minority of patients receiving second generation antipsychotic medications, adequate doses will be Risperidone 4mg/day, or Olanzapine 10mg/day.
• Presence of at least moderate symptom severity measured according to the PANSS (score of at least 75)
• On adequate dose of antipsychotic medication at entry and throughout the trial period except during medication switch when participant may take lower doses
• Both genders, but women have to be of non-child bearing age because of potential risks to pregnant women, and the difficulty of ensuring contraception

You may not qualify if:

• Substance abuse co-morbidity or history of substance abuse/dependence within the previous three months
• Impaired cognitive capacity because of a degenerative brain condition or trauma or diagnosis of mental retardation
• Any serious medical condition that affects brain or cognitive function (e.g. epilepsy, serious head injury, brain tumor or other neurological and neurodegenerative conditions)
• Any clinically significant or unstable medical disorder as determined by the investigators that would preclude study participation, including congestive heart failure, abnormal liver function or disease, renal impairment. Also patients with leucopenia, anemia and thrombocytopenia will be excluded.
• History of hypersensitivity to tetracycline
• Patients on anticoagulant therapy
• Patients requiring ergot alkaloids
• Patients taking antacids containing aluminum, calcium or magnesium and iron containing products
• Women of childbearing age (age 18-49 years)
• Increased risk of suicide

Sponsors & Collaborators

• Addis Ababa University: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Amanuel Psychiatric Hospital

Addis Ababa, Ethiopia

Location

Related Publications (1)

• Fekadu A, Mesfin M, Medhin G, Alem A, Teferra S, Gebre-Eyesus T, Seboxa T, Assefa A, Hussein J, Lemma MT, Borba C, Henderson DC, Hanlon C, Shibre T. Adjuvant therapy with minocycline for schizophrenia (The MINOS Trial): study protocol for a double-blind randomized placebo-controlled trial. Trials. 2013 Nov 27;14:406. doi: 10.1186/1745-6215-14-406.

  PMID: 24279305 DERIVED

MeSH Terms

Conditions

Schizophrenia

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

• Abebaw Fekadu, MD, PhD

  Addis Ababa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 12, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 30, 2016

Record last verified: 2016-06

Locations

ET (1)