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New study pits two therapies against each other for stubborn depression

NCT ID NCT04996433

Symptom relief Sponsor: University of Greifswald Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of talk therapy—CBASP and Behavioral Activation—for adults with long-lasting depression that hasn't improved with other treatments. About 396 inpatients will receive 16 weeks of one therapy to see which works better and why. The goal is to find more effective ways to ease symptoms in people with treatment-resistant depression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 396 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Primary DSM-5 diagnosis of PDD (300.4, 296.2x, 296.3x) * Total Hamilton Depression Rating Scale (HDRS-24) Score ≥ 20 * Treatment-resistance (TR) (defined by the ATHF-SF or medication intolerance or one psychotherapy at least 25 sessions by a certified therapist in the current episode) * Sufficient knowledge of the German language * Written informed consent Exclusion Criteria: * Bipolar I or II disorder * Active substance use disorders (abstinence shorter than 6 months) * Schizophrenia spectrum and other psychotic disorders * Antisocial personality disorder * Acute suicidality (HRSD item 3 \> 2 or agreement with C-SSRS item 4 and/or item 5) * Previous CBASP or BA treatment within the last year * Inability to tolerate CBASP or BA (e.g., organic brain disorders, severe cognitive deficits) * Inability to participate in dayclinic or outpatient continuation treatment * Participation in another (psycho)therapeutic study of an interventional nature

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Conditions

The condition(s) this trial relates to.

Depression Depressive Disorder, Treatment-Resistant dysthymic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Persistent depressive disorder Treatment-resistant depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Charité, University Medicine Berlin

    RECRUITING

    Berlin, State of Berlin, 10117, Germany

  • Klinikum der Universität München

    RECRUITING

    München, 80336, Germany

  • Medizinische Hochschule Hannover

    TERMINATED

    Hanover, 30625, Germany

  • Universität zu Lübeck

    RECRUITING

    Lübeck, 23562, Germany

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Universitätsklinikum Jena

    RECRUITING

    Jena, 07743, Germany

  • Universitätsklinikum Marburg

    RECRUITING

    Marburg, 35039, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, 72076, Germany

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