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New treatment option for Persistent Depressive Disorder
Official title A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
ClinicalTrials.gov ID: NCT04996433
What this study is testing
What is algorithm-based study medication?
algorithm-based study medication is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for persistent depressive disorder.
Also referred to as antidepressant medication.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to compare the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) conducted over 16 weeks (acute and continuation treatment) with Behavioral Activation (BA; same dose and duration) in persistently depressed treatment-resistant inpatients regarding efficacy, moderators and mediators of change.
- Time commitment: about 16 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Sufficient knowledge of the German language
- Written informed consent
You likely can't join if
- 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
See the full eligibility 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
- 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 treatment nature
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, State of Berlin, Germany
- Bonn, Germany
- Hanover, Germany
- Jena, Germany
- Lübeck, Germany
- Marburg, Germany
- München, Germany
- Tübingen, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, State of Berlin, Germany; Bonn, Germany; Hanover, Germany; Jena, Germany; Lübeck, Germany; Marburg, Germany and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.