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Completed

NCT Number: NCT00560937

Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia

This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The goal of this placebo-controlled study is to provide preliminary efficacy data for potential pregnenolone effects on cognitive symptoms and negative symptoms in patients with schizophrenia. Depressive symptoms and positive symptoms will also be assessed.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VAMC

Durham, North Carolina, 27705, United States

About this study

See brief summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years of age, any ethnic group, either sex
  • Diagnostic and Statistical Manual, 4th edition (DSM IV) diagnosis of schizophrenia or schizoaffective disorder
  • Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.
  • Patient cohort enriched for moderate to severe cognitive symptoms (composite Brief Assessment of Cognition in Schizophrenia (BACS) score 0-3 SD below the mean).
  • No change in antipsychotic for 8 weeks or longer. No change in antipsychotic dose for 4 weeks or longer.
  • No change in anticholinergic, benzodiazepine, or mood stabilizer medications for 4 weeks or longer.
  • No anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 10-week duration of the study.

Exclusion criteria

  • Unstable medical illness or neurologic illness (seizures, cerebrovascular accident); history of prostate, breast, uterine, or ovarian cancer.
  • Use of oral contraceptives or other hormonal supplementation such as estrogen.
  • Other concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
  • Active expression of suicidal or homicidal ideation.
  • Comorbid substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
  • Female patients who are pregnant or breast-feeding.
  • Known allergy to study medication.
  • Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc) will be excluded as suggested by the Federal Drug Administration (FDA); patients taking these agents will not be eligible for this study.

Treatment and study plan

Pregnenolone

Drug

Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks

Placebo

Drug

Placebo (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID x 4 weeks

Primary outcomes

  1. Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048

    Time frame: SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)

    The SANS assesses negative symptoms in schizophrenia. The SANS consists of 21 clinical interview questions assessing negative symptoms of schizophrenia. Each question is rated on a scale of 0 (no symptoms) to 7 (severe symptoms).

  2. Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)

    Time frame: Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)

    The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.

  3. Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)

    Time frame: Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)

    The MATRICS is a battery for the assessment of cognitive symptoms in patients with schizophrenia. Composite T-scores are calculated (T-score ranges are -20 to +80, and are normed on gender and age). Higher scores are indicative of better cognitive performance, lower scores are indicative of poorer cognitive performance.

Secondary outcomes

  1. Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS)

    Time frame: Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward)

    The CDSS is used measure to investigate depressive symptoms in schizophrenia. The measure includes 9 questions ranked from 0 (no symptoms) to 3 (severe symptoms). Range of possible scores: 0-27.

  2. Clinical Global Impression Scale (CGI-I)

    Time frame: CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward)

    The CGI-I is a commonly used psychiatric scale to assess overall general improvement. The CGI-I consists of one interviewer-rated question on a scale of 1-7. Lower scores are indicative of fewer symptoms; while higher scores are indicative of more symptoms.

  3. Mean Score on the Positive and Negative Symptom Scale (PANSS)

    Time frame: Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)

    The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.

Sponsors and collaborators

Lead sponsor

Durham VA Medical Center

Fed

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Nov 20, 2007
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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