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

NCT00847600 | Completed Phase 4

• 2 other identifiers: MEN-8-11-0808TGF-1189 Stanley grant
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the central nervous system, and may be beneficial in the treatment of patients with schizophrenia. Our recent 8-week, randomized, double-blind trial among patients with chronic schizophrenia and schizoaffective disorders, in which PREG versus placebo and DHEA have been added to conventional or atypical antipsychotics have yielded encouraging results with low-dose PREG (30 mg/day; ClinicalTrials.gov identifier NCT00140192; Ritsner et al., in press). The goal of the present study is to evaluate the potential role of PREG's augmentation compared to placebo in the treatment of young patients with newly diagnosed schizophrenia or schizophreniform or schizoaffective disorders. In a 8-week, randomized, double-blind placebo-controlled trial PREG (50 mg/day) or placebo capsules will be added to the stable ongoing antipsychotic treatment of 60 patients with recent-onset schizophrenia or schizophreniform or schizoaffective disorders. 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 assessment of psychopathology, cognitive functions, side effects, general functioning and quality of life. In addition blood PREG levels will be monitored at baseline and during the study. The study is powered to detect moderate between-group effects on persistent positive, negative and cognitive symptoms.

Conditions

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorders

Keywords

Schizophrenia; Neurosteroids; Pregnenolone; Augmentation

Outcome Measures

Primary Outcomes (1)

• The Clinical Global Impression Scale (CGI-S) The Positive and Negative Syndrome Scale (PANSS) The Scale for the Assessment of Negative Symptoms (SANS)

  baseline, 2, 4, 6, and 8 weeks

Secondary Outcomes (3)

• Global Assessment of Functioning

  baseline, 2, 4, 6, and 8 weeks

• The Cambridge Neuropsychological Test Automated Battery (CANTAB)

  baseline, 4 and 8 weeks

• Extrapyramidal Symptom Rating Scale

  baseline, 2, 4, 6, and 8 weeks

Study Arms (2)

1 Pregnenolone

EXPERIMENTAL

50 mg/day

Dietary Supplement: Pregnenolone

2 Placebo

PLACEBO COMPARATOR

1 caps.

Dietary Supplement: Placebo

Interventions

Pregnenolone DIETARY_SUPPLEMENT

50 mg, caps.

1 Pregnenolone

Placebo DIETARY_SUPPLEMENT

caps

2 Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sha'ar Menashe Mental Health Center: lead
• Tirat Carmel Mental Health Center: collaborator

Study Sites (1)

Shaar Menashe MHC and Tirat Carmel MHC

Hadera, 38814, Israel

Location

Related Publications (1)

• Ritsner M, Maayan R, Gibel A, Weizman A. Differences in blood pregnenolone and dehydroepiandrosterone levels between schizophrenia patients and healthy subjects. Eur Neuropsychopharmacol. 2007 Apr;17(5):358-65. doi: 10.1016/j.euroneuro.2006.10.001. Epub 2006 Nov 21.

  PMID: 17123790 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Michael S Ritsher, MD, PhD

  Technion and Shaar Menashe MHC

  STUDY CHAIR

• Anatoly Kreinin, MD, PhD

  Technion and Tirat Carmel Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 15, 2010

Record last verified: 2010-12

Locations

IL (1)