Phase 2 Schizophrenia Trial, Recruiting NCT06881810 Sponsor: Central Institute of Mental Health, Mannheim Condition: Schizophrenia
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Phase 2 Schizophrenia Trial, Recruiting

NCT06881810
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 64 years.
  • People who are able to give written consent before joining the trial.
  • People who have been diagnosed with schizophrenia or another primary psychotic disorder (confirmed using a specific diagnostic interview called the MINI-DIPS-OA).
  • People who have at least one negative symptom of schizophrenia (such as reduced motivation or emotional expression) rated as moderate or worse on a standard symptom scale at the start of the trial.
  • People who are receiving psychosocial treatment (either as an inpatient or outpatient) at least twice a week throughout the study.
  • Male participants, female participants who are not able to become pregnant, or female participants of childbearing potential who are using a highly effective, medically approved form of contraception at the time of screening.

Who may not be able to join:

  • People the investigator considers unsuitable for the study, including those who are considered acutely at risk of suicide.
  • People who are currently receiving treatment under legal compulsion (involuntary treatment).
  • People with a primary diagnosis of substance dependency (other than nicotine), including alcohol dependency — though people who have been in remission from a substance use disorder for more than 3 months, or who have a low-severity substance use disorder, may still be considered eligible (confirm with trial site).
  • People who have a known intolerance or allergy to the study drug or any of its ingredients.
  • People who are pregnant (including a positive pregnancy test), breastfeeding, or lactating.
  • People with a severe hormonal (endocrine) disorder, apart from diabetes.
  • People with a diagnosis of endometriosis.
  • People who are currently taking part in another clinical trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Dusan Hirjak, Prof. Dr., Central Institute of Mental Health

Phone: 0621 1703

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Central Institute of Mental Health, Mannheim
Registry
ClinicalTrials.gov
Start date
29 August 2024
Est. completion
31 March 2028

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Personal and Social Performance Scale (PSP)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov