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SchizophreniaPhase 2NCT02926859

Enhancing Recovery in Early Schizophrenia

A Phase 2 study testing Cannabidiol as add-on in people with Schizophrenia, run by Central Institute of Mental Health, Mannheim at 6 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Current antipsychotic treatments of schizophrenia are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no psychotomimetic or addictive properties. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Cannabidiol as add-on
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
6 sitesGermany
Study dates
8 Apr 2017to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent given by the subject
  • DSM-IV-TR diagnosis of schizophrenic psychosis (295.10-30, 295.90)
  • First documented diagnosis of schizophrenia must not be no older than seven years.
  • Patients must receive a stable dose of amisulpride, aripiprazole, olanzapine, quetiapine or risperidone (TAU: treatment as usual) at least 4 weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received.
  • Initial PANSS total score of ≤ 75 at baseline.
  • proper contraception in female patients of childbearing potential
  • body mass index between 18 and 40.

Who cannot join

  • Lack of accountability
  • positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
  • serious suicidal risk at screening visit
  • other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
  • other relevant neurological or other medical disorders
  • pregnancy or lactation.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Dept. of Psychiatry and Psychotherapy, Charité, Campus Charité-Mitte

    Berlin, B, 10117

  • Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne

    Cologne, North Rhine-Westphalia, 50924

  • Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf

    Hamburg, 20246

  • Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health

    Mannheim, Baden-Wurttemberg, 68159

  • Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich

    Munich, Bavaria, 80336

Other trials in Germany

About this study

Official title: Enhancing Recovery in Early Schizophrenia - a Multi-center, Two-arm, Double-blind, Randomized Phase II Trial Investigating Cannabidiol vs. Placebo as an add-on to an Individualized Antipsychotic Treatment

Current antipsychotic treatments of schizophrenia are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in acute paranoid schizophrenia we showed a statistically significant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a significantly superior side-effect profile in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profile and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an established treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months, double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's antipsychotic potential will be gained.

Conditions
Schizophrenia
Being tested
Cannabidiol as add-on, Placebo as add-on
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabidiol as add-onDrug

    Cannabidiol capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks

  • Placebo as add-onDrug

    Placebo capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks

Study groups in NCT02926859
Study groupRoleWhat they receive
CannabidiolExperimentalCannabidiol as add-on to individualized pharmacological treatment
Receives: Drug: Cannabidiol as add-on
PlaceboPlacebo comparatorPlacebo as add-on to individualized pharmacological treatment
Receives: Drug: Placebo as add-on

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause discontinuation

    Measured: within 12 month

Secondary outcomes (18)

  1. Improvement in Psychopathology assessed by PANSS

    Positive and Negative Syndrome Scale (PANSS)

    Measured: 6, 9 and 12 month

  2. Improvement in Psychopathology assessed by CGI

    Clinical Global Impression (CGI)

    Measured: 6, 9 and 12 month

  3. Improvement in Psychopathology assessed by BSI-53

    Brief Symptom Inventory (BSI-53)

    Measured: 6, 9 and 12 month

  4. Improvement in Psychopathology assessed by FROGS

    Functional Remission of General Schizophrenia (FROGS)

    Measured: 6, 9 and 12 month

  5. Changes from baseline in Depression Scale

    Calgary Depression Scale for Schizophrenia (CDSS)

    Measured: 6, 9 and 12 month

  6. Improvement in social and occupational functioning assessed by GAF

    Global Assessment of Functioning (GAF)

    Measured: 6, 9 and 12 month

  7. Improvement in social and occupational functioning assessed by PSP

    Personal and Social Performance Scale (PSP)

    Measured: 6, 9 and 12 month

  8. Improvement in social and occupational functioning assessed by EMA

    Ecological Momentary Assessment (EMA)

    Measured: 6, 9 and 12 month

  9. Improvement in Quality of life assessed by WHOQUOL-Bref

    WHO Quality of Life-Bref (WHOQUOL-Bref)

    Measured: 6, 9 and 12 month

  10. Improvement in Quality of life assessed by LQLP

    Lancashire Quality of Life Profile (LQLP)

    Measured: 6, 9 and 12 month

  11. Changes from baseline in Neurocognition assessed by B-CATS

    Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)

    Measured: 6, 9 and 12 month

  12. Changes from baseline in Neurocognition assessed by BACS

    Brief Assessment of Cognition in Schizophrenia (BACS)

    Measured: 6, 9 and 12 month

  13. Changes from baseline in Neurocognition assessed by UPSA-B

    University of California San Diego Performance based Skills Assessment (UPSA-B)

    Measured: 6, 9 and 12 month

  14. Changes from baseline in Neurocognition assessed by MASC

    Movie for the Assessment of Social Cognition (MASC)

    Measured: 6, 9 and 12 month

  15. Changes from baseline in Neurocognition assessed by PFA

    Pictures of Facial Affect (PFA)

    Measured: 6, 9 and 12 month

  16. Treatment adherence

    Measured: 6, 9 and 12 month

  17. Changes in Cumulative dose of concomitant or rescue medication

    Measured: 6, 9 and 12 month

  18. Changes of Biomarker: alterations of endocannabinoids and lipdomic profiling

    Measured: 6, 9 and 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study start8 Apr 2017
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02926859
Sponsor's protocol ID
CBD-ESPRIT
Status last verified
Jan 2026
First submitted
7 Jul 2016
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabidiol as add-on in people with Schizophrenia, run by Central Institute of Mental Health, Mannheim at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause discontinuation (time frame: within 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02926859.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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