Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia

Inclusion criteria

• 18-40 years of age, any ethnic group, either sex.
• DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorders (36).
• Duration of illness less than 5 years since onset first psychotic episode.
• Subjects entering the study must score at least 4 on the Clinical Global Impression Scale.
• At least two weeks of ongoing treatment with current antipsychotic agents during the pre-treatment stabilization period.
• Stable symptoms throughout the 2-week pre-treatment stabilization period. 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.
• No change in anticholinergic, benzodiazepine, or mood stabilizer medications for the pre-treatment stabilization period.
• No anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 8-week duration of the study.
• Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.

Exclusion criteria

• Evidence of serious neurologic or endocrine disorder, for example severe head trauma, seizure disorder, dementia, Cushings disease, or thyroid disorder, mental retardation, alcohol or drug abuse, substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
• Unstable medical illness or neurologic illness (seizures, CVA); history of prostate, breast, uterine, or ovarian cancer.
• Pregnant women, use of oral contraceptives or other hormonal supplementation such as estrogen.
• Current active suicidal and/or homicidal ideation, intent, or plan.
• Known allergy to study medication.