Autism & Developmental

Brief report: an open-label study of the neurosteroid pregnenolone in adults with autism spectrum disorder.

Fung et al. (2014) · Journal of autism and developmental disorders 2014
★ The Verdict

Pregnenolone slightly lowered irritability in adults with autism, but without a control group the effect could be placebo.

✓ Read this if BCBAs helping adults with ASD who ask about supplements.
✗ Skip if Clinicians only serving young children or those happy with current meds.

01Research in Context

01

What this study did

Doctors gave adults with autism a daily pill of pregnenolone for 12 weeks. They tracked irritability and energy before and after. No placebo group was used.

02

What they found

Irritability and lethargy dropped a little. The change was real enough to pass a stats test. The pill was easy to swallow and caused no big side effects.

03

How this fits with other research

Broadstock et al. (2007) warned that almost no solid drug studies exist for adults with autism. This open trial adds one more small drop to that near-empty bucket.

Konstantareas et al. (1999) tested a different supplement, dimethylglycine, in a proper crossover design and saw zero benefit. The new pregnenolone study lacks a control group, so the small gains could still be placebo.

Saré et al. (2020) and Thomas et al. (2021) both showed adults with autism can gain ground through jobs and coaching, not pills. Together the papers say: behavioral and vocational routes have proof; drug routes still rest on shaky sand.

04

Why it matters

You may meet adults with autism who feel edgy or flat. Pregnenolone is not ready for your toolkit yet. Track behavior if a doctor runs a trial, but lean on programs like JOBSS or community work that already show stronger gains.

Free CEUs

Want CEUs on This Topic?

The ABA Clubhouse has 60+ free CEUs — live every Wednesday. Ethics, supervision & clinical topics.

Join Free →
→ Action — try this Monday

Start a simple irritability log with your client before any new pill so you have baseline data.

02At a glance

Intervention
not applicable
Design
pre post no control
Sample size
12
Population
autism spectrum disorder
Finding
positive
Magnitude
small

03Original abstract

The objective of this study was to assess the tolerability and efficacy of pregnenolone in reducing irritability in adults with autism spectrum disorder (ASD). This was a pilot, open-label, 12-week trial that included twelve subjects with a mean age of 22.5 ± 5.8 years. Two participants dropped out of the study due to reasons unrelated to adverse effects. Pregnenolone yielded a statistically significant improvement in the primary measure, Aberrant Behavior Checklist (ABC)-Irritability [from 17.4 ± 7.4 at baseline to 11.2 ± 7.0 at 12 weeks (p = 0.028)]. Secondary measures were not statistically significant with the exception of ABC-lethargy (p = 0.046) and total Short Sensory Profile score (p = 0.009). No significant vital sign changes occurred during this study. Pregnenolone was not associated with any severe side effects. Single episodes of tiredness, diarrhea and depressive affect that could be related to pregnenolone were reported. Overall, pregnenolone was modestly effective and well-tolerated in individuals with ASD.

Journal of autism and developmental disorders, 2014 · doi:10.1089/cap.2008.093