Adjuvant therapy with minocycline for schizophrenia (The MINOS Trial): study
protocol for a double-blind randomized placebo-controlled trial.
Author(s): Fekadu A(1), 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.
Affiliation(s): Author information:
(1)Department of psychiatry, School of Medicine, College of Health Sciences, Addis
Ababa University, Addis Ababa, Ethiopia. abe.wassie@kcl.ac.uk.
Publication date & source: 2013, Trials. , 14:406
BACKGROUND: 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 indicate that minocycline may be beneficial adjunct in the
treatment of schizophrenia: positive, negative, and cognitive symptoms.In this
study we aim to assess the efficacy of adjunctive minocycline to alleviate
symptoms of schizophrenia in patients who have failed to respond to a therapeutic
trial of antipsychotic medications.
METHODS: The study is a parallel group, double-blind, randomized,
placebo-controlled trial. Participants will be adults (aged 18 years and above)
with first episode or relapse episode of schizophrenia of under 5 years'
duration. Patients who failed to show adequate therapeutic response to at least
one antipsychotic medication given for a minimum of 4 weeks will be recruited
from a psychiatry hospital in Addis Ababa and a psychiatry clinic in Butajira,
Ethiopia. A total of 150 participants (75 in each arm) will be required to detect
a five-point mean difference between the intervention arms adjusting for baseline
symptom severity, at 90% power and 95% confidence. Patients in the intervention
arm will receive minocycline (200 mg/day orally) added on to the regular
antipsychotic medications participants are already on. Those in the placebo arm
will receive an inactive compound identical in physical appearance to
minocycline. Intervention will be offered for 12 weeks. Diagnosis will be
established using the operational criteria for research (OPCRIT). Primary outcome
measure will be a change in symptom severity measured using the positive and the
negative syndrome scale for schizophrenia (PANSS). Secondary outcome measures
will include changes in severity of negative symptoms, proportion achieving
remission, and level of functioning. Whether changes are maintained post
intervention will also be measured (PANSS). Key assessment for the primary
outcome will be conducted at the end of trial (week 12). One post-intervention
assessment will be conducted 4 weeks after the end of intervention (week 16) to
determine sustainability of change.
TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01809158.
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