This a randomized double-blind placebo controlled trial which aims to determine the beneficial effects of minocycline augmentation to clozapine in partial responders to Treatment Resistant Schizophrenia (TRS).
The primary objective is to determine if the addition of minocycline to Clozapine, Treatment as Usual (TAU) Improves negative symptoms and/or positive symptoms. The secondary objectives are to determine: * Effects on cognitive functioning. * Effects on social functioning and quality of life. * Safety and tolerability. * Possible additive effects of Minocycline added to TAU * The effect on inflammatory biomarkers associated with schizophrenia. Both pro and anti-inflammatory cytokines will be drawn at baseline and endpoint. We will test to see if minocycline is associated with improvements in abnormal cytokines as compared to placebo. The study will be a randomized double-blind placebo controlled trial of minocycline added to clozapine (Treatment as Usual) in TRS. There will be two treatment arms: one arm receiving TAU with minocycline and the other TAU with placebo for a period of twelve weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Minocycline 200mg per day
Abasi Shaheed Hospital
Karachi, Sindh, Pakistan
RECRUITINGCivil hospital Karachi
Karachi, Sindh, Pakistan
RECRUITINGKarwn e Hayat
Karachi, Sindh, Pakistan
RECRUITINGPositive and Negative Syndrome Scale PANSS
PANSS is an assessment measures to assess severity of symptoms of schizophrenia
Time frame: 3 months
CogState
Measuring all seven domains recommended by MATRICS (NIMH initiative). These domains include speed processing, attention/vigilance, Working memory (nonverbal \& verbal), verbal learning, visual learning, reasoning and problem solving and social cognition's.
Time frame: 3 Month
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Institute of Behavioral Sciences
Karachi, Sindh, Pakistan
RECRUITING