Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing DEX IR tablets for Attention-Deficit/Hyperactivity Disorder (ADHD)

The indication of attention-deficit/hyperactivity disorder (ADHD) to be examined often occurs with other psychiatric disorders, and the majority of adults with ADHD have at least one psychiatric comorbidity in their lives. Depression is one of the most common comorbidities in patients with ADHD.

Official registry: https://clinicaltrials.gov/study/NCT06967857 · Prof. Dr. Frank Behrens · enrollment listed as 105

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are DEX IR tablets, DEX XL, or Placebo. The registry lists allocation as randomized. The indication of attention-deficit/hyperactivity disorder (ADHD) to be examined often occurs with other psychiatric disorders, and the majority of adults with ADHD have at least one psychiatric comorbidity in their lives.

They plan to enroll about 105 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Randomized, Placebo-controlled Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression (DEXAD)

Interventions: DEX IR tablets, DEX XL, Placebo

Primary outcome (registry wording): Incidence of adverse events (AE) in the active treatment groups compared to the placebo until V6

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Patient has a minimum ADHS-Diagnostische Checkliste-Q (ADHS-DC) total score of 32 at baseline (Visit (V) 0)
  • Moderate to severe depression according to ICD-10 (depressive episode: Code F32; recurrent depressive disorder: Code F33) and with a Montgomery-Åsberg Depression Rating Scale (MADRS) score of \>20 at baseline (V0)
  • CGI-S ≥ 4 at baseline (V0)
  • Patients receiving selective serotonin reuptake inhibitors (SSRIs) or Serotonin-norepinephrine reuptake inhibitors (SNRIs) (stable doses within the last 2 weeks before inclusion) (≤40 mg (es)citalopram, 50-200 mg sertraline, 75 - 300 mg venlafaxine extended release)
  • Male or female patients ≥ 18 years and ≤ 65 at time of enrolment
  • Patients with QTc interval within normal ranges (≤470 ms in males and ≤480 ms in females)
  • Willing and able to comply to study procedures and study protocol

Public study contact (from the registry)

Christin Jonetzko

+49 69 630180210

christin.jonetzko@itmp.fraunhofer.de

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

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National Pregnancy Registry for Psychiatric Medications

The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.

NCT01246765 · Official ClinicalTrials.gov record · Massachusetts General Hospital

FAQ about this NCT record

Is NCT06967857 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06967857?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06967857?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary