Schizophrenia Clinical Trial
Official title:
Addition of Both Pregnenolone and L-theanine to Ongoing Antipsychotic Treatment for Schizophrenia and Schizoaffective Disorders: an 8-week, Randomized, Double-blind, Placebo-controlled Multicenter Study
Schizophrenia (SZ) and schizoaffective (SA) disorders are comprised of several debilitating
symptoms. It was suggested that compounds with neuroprotective effects might be useful in
the management of SZ/SA symptoms. Our previous clinical trials indicated significant
beneficial effects for augmentations with two different neuroprotective agents: Pregnenolone
and L-Theanine. Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on
the central nervous system. Our recent 8-week, randomized, double-blind trial among patients
with chronic SZ/SA disorders, in which PREG versus placebo and DHEA was added to
antipsychotics, yielded encouraging results: PREG augmentation demonstrated significant
amelioration of positive symptoms, EPS, as well as an improvement in attention, and working
memory performance of SZ/SA disorder patients (Ritsner et al 2010). L-Theanine is a unique
amino acid present almost exclusively in the tea plant. It possesses neuroprotective,
mood-enhancing, and relaxation activities. L-theanine augmentation to antipsychotic therapy
can ameliorate positive, activation, and anxiety symptoms in SZ/SA disorder patients (grant
# 06TGF-911, (Ritsner et al 2010). This proposed study would extend our prior research with
Pregnenolone and L-theanine by combining both agents versus placebo. We hypothesized that
addition of both these compounds to ongoing antipsychotics would significantly improve the
clinical status of SZ/SA patients.
Methods: In an 8-week, randomized, double-blind placebo-controlled trial a combination of
PREG (50 mg/day) with L-theanine (400 mg/day) versus placebo will be added to the stable
ongoing antipsychotic treatment of 200 patients with schizophrenia or schizoaffective
disorders. This trial will be conducted at five sites in Israel. Participants will be
assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of research
instruments will be used for the assessment of psychopathology, side effects, general
functioning and quality of life
This is a two-year randomized placebo-controlled double-blind investigation of the
augmentation of PREG with L-theanine in the management of patients with SZ/SA. The study
will consist of two phases: a 2-week continued stability (lead in) phase and an 8-week
double-blind treatment phase. In the lead-in phase, patients receiving antipsychotic
medication will remain on their maintenance regimen for at least two weeks. Clinical
stability is defined as two consecutive weekly CGI ratings with no change in score, and with
no more than a 20% change in PANSS total score. The treatment phase will be 8-week parallel
groups, placebo-controlled, double-blind trial of adjunctively administered PREG with
L-theanine or placebo. Assignment to PREG with L-theanine or placebo will be on a random,
stratified (i.e., FGAs/SGAs, inpatient/outpatient) basis. PREG (50 mg/day) with L-theanine
(400 mg/day) and placebo will be administered in divided doses in the form of capsules. If a
patient relapses during the treatment phase of the study, the patient will be removed from
the study. All attempts will be made to obtain end-of-study ratings. If such measures cannot
be obtained, four- and six-week data, if collected prior to relapse, will be informative.
Patients who fulfill the entry criteria will enter the 8-week double-blind treatment phase
of the study. Assignment to PREG with L-theanine or placebo will be on a random, stratified
(i.e., conventional/new generation antipsychotic treatment, inpatient/outpatient) basis.
PREG (50 mg/day) with L-theanine (400 mg/day)/placebo will be administered in divided doses
in the form of white capsules. If a patient relapses during the treatment phase of the
study, the patient will be removed from the study. All attempts will be made to obtain
end-of-study ratings. If such measures cannot be obtained, four- and eight-week data, if
collected prior to relapse, will be informative.
Subjects will be assessed at baseline and after 2, 4, 6, and 8 weeks of treatment using
psychiatric rating scales, and self-report questionnaires. Neurobiological (plasma cortisol,
PREG, dehydroepiandrosterone, BDNF and other biologically active molecules) and
immunological (the pro-inflammatory cytokines and others) testing will be conducted at
baseline, and after treatment. The efficacy and safety of augmenting antipsychotic treatment
of PREG with L-theanine will be analyzed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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