Add-on Pregnenolone with L-Theanine to Antipsychotic Therapy Relieves Negative
and Anxiety Symptoms of Schizophrenia: An 8-week, randomized, double-blind,
placebo-controlled trial.
Author(s): Kardashev A(1), Ratner Y(1,)(2), Ritsner MS(1,)(2).
Affiliation(s): Author information:
(1)1 Sha'ar Menashe Mental Health Center, Hadera, Israel. (2)2 The Rappaport
Faculty of Medicine, Technion, Haifa, Israel.
Publication date & source: 2015, Clin Schizophr Relat Psychoses. ,
AIMS: Pregnenolone (PREG) and L-Theanine (LT) have shown ameliorative effects on
various schizophrenia symptoms. This is the first study to evaluate the efficacy
and safety of augmentation of antipsychotic treatment among patients with chronic
schizophrenia or schizoaffective disorder with PREG - LT.
METHODS: Double-blind, placebo-controlled trial of PREG - LT or placebo
augmentation was conducted for 8 weeks with 40 chronic DSM-IV schizophrenia and
schizoaffective disorder patients with suboptimal response to antipsychotics.
Oral PREG (50 mg/day) with LT (400 mg/day) or placebo were added to a stable
regimen of antipsychotic medication from March 2011 to October 2013. The
participants were rated using the Scale for the Assessment of Negative Symptoms
(SANS), Hamilton Scale for Anxiety (HAM-A), and Positive and Negative Syndrome
Scale (PANSS) scales bi-weekly. The decrease of SANS and HAM-A scores were the
co-primary outcomes. Secondary outcomes included assessments of general
functioning and side effects.
RESULTS: Negative symptoms such as blunted affect, alogia, and anhedonia (SANS)
were found to be significantly improved, with moderate effect sizes among
patients who received PREG-LT, in comparison with the placebo group. Add-on
PREG-LT also significantly associated with a reduction of anxiety scores such as
anxious mood, tension, and cardiovascular symptoms (HAM-A), and elevation of
general functioning (GAF). Positive symptoms, antipsychotic agents, concomitant
drugs, and illness duration did not associate significantly with effect of
PREG-LT augmentation. PREG-LT was well-tolerated.
CONCLUSIONS: Pregnenolone with L-Theanine augmentation may offer a new
therapeutic strategy for treatment of negative and anxiety symptoms in
schizophrenia and schizoaffective disorder. Further studies are warranted.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01831986.
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