Summary
Amphetamine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Anxiety Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Anxiety Disorders. ClinicalTrials.gov lists 8 registered trials linking Amphetamine to Anxiety Disorders: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01863459). The largest enrolment is 90 participants (NCT05138068). Registration activity spans 2006 to 2022. The literature layer holds 7 publications for this pair: 1 meta-analysis, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 1983 to 2018. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Anxiety ranks 535 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: GAD: spontaneous remission in ~25-30% at 1 year without treatment; social anxiety: 36% remission at 12 years untreated; panic disorder: 50-65% spontaneous partial remission but relapse common; 40-60% remain symptomatic at 5 years.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 59.5 (trials 22.5, literature 17.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 7 (5 clinical trial publications, 1 meta-analysis, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ADRA1A |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01863459 | Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity 2013 | completed | Phase 4 | 42 |
| NCT02008396 | Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults 2014 | completed | Phase 2 | 12 |
| NCT02427568 | MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness 2015 | completed | Phase 2 | 18 |
| NCT05138068 | Social Anxiety MDMA-Assisted Therapy Investigation 2022 | completed | Phase 2 | 90 |
| NCT00252174 | MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer 2007 | terminated | Phase 2 | 2 |
| NCT04993300 | Repetitive Transcranial Magnetic Stimulation in Amphetamine Addiction 2022 | completed | Not applicable | 5 |
| NCT00363298 | Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD 2006 | completed | Not applicable | 24 |
| NCT05535101 | Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder 2022 | status unknown | Not applicable | 60 |
Published literature
- Meta-analysis Adverse drug events related to mood and emotion in paediatric patients treated for ADHD: A meta-analysisPozzi M, Carnovale C, Peeters GGAM et al. · Journal of affective disorders · 2018 · PMID 29883938
- Clinical trial publication The mixed amphetamine salt extended release (Adderall XR, Max-XR) as an adjunctive to SSRIS or SNRIS in the treatment of adult ADHD patients with comorbid partially responsive generalized anxiety: an open-label studyGabriel A · Attention deficit and hyperactivity disorders · 2010 · PMID 21432593
- Clinical trial publication Double-blind study of dextroamphetamine versus caffeine augmentation for treatment-resistant obsessive-compulsive disorderKoran LM, Aboujaoude E, Gamel NN · The Journal of clinical psychiatry · 2009 · PMID 19573497
- Clinical trial publication Mechanisms of dopaminergic and serotonergic neurotransmission in Tourette syndrome: clues from an in vivo neurochemistry study with PETWong DF, Brasić JR, Singer HS et al. · Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2008 · PMID 17987065
- Clinical trial publication Changes in EEG mean frequency associated with anxiety and with amphetamine challenge in BPDCornelius JR, Schulz SC, Brenner RP et al. · Biological psychiatry · 1988 · PMID 3048424
- Clinical trial publication A naturalistic study of imipramine in panic disorder and agoraphobiaAronson TA · The American journal of psychiatry · 1987 · PMID 3300374
- Randomized controlled trial D-amphetamine in obsessive-compulsive disorderInsel TR, Hamilton JA, Guttmacher LB et al. · Psychopharmacology · 1983 · PMID 6412267
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADRA1A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Amphetamine approved for Anxiety Disorders?
Amphetamine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Anxiety Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Anxiety Disorders. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Amphetamine in clinical trials for Anxiety Disorders?
ClinicalTrials.gov lists 8 registered trials linking Amphetamine to Anxiety Disorders: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01863459). The largest enrolment is 90 participants (NCT05138068). Registration activity spans 2006 to 2022.
What does the evidence show for Amphetamine in Anxiety Disorders?
Amphetamine has both completed registered trials and synthesis-level publications linked to Anxiety Disorders. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADRA1A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.