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Childhood Trauma's lasting mark on bipolar brains under the microscope

NCT ID NCT07101107

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 2 times

Summary

This study looks at how emotional childhood maltreatment (like verbal abuse or neglect) affects social skills, brain structure, and inflammation in people with bipolar disorder. Researchers will compare 80 people with bipolar disorder and 80 healthy controls, using brain scans, blood tests, and empathy tasks. The goal is to understand the links between early trauma and later mental health, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how childhood maltreatment impacts social skills and brain health in bipolar disorder, pointing toward better support strategies.
What could go wrong
This is an observational study, not a treatment trial. It is early-stage and may not find clear links or apply to everyone with bipolar disorder.

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.

Participants

About 160 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Feb 2030

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.

Who is studied

For bipolar disorder with a current diagnosis of depressive episode: Inpatient clinic of the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology of the Medical University Innsbruck. For healthy controls: recruitment is done via public advertisements (e.g. posters, flyers, local newspaper announcements) and at the homepage of Medical University Innsbruck, Tirol Kliniken, and University of Innsbruck.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 for individuals diagnosed with bipolar disorder (BD): * diagnosis of a moderate to severe depressive episode without psychotic features in the context of BD-I according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5: 296.52 BD-I, most recent episode depressed, moderate; 296.53 BD-I, most recent episode depressed, severe without psychotic features; * Montgomery-Åsberg Depression Rating Scale (MADRS) score≥20; * age between 18 and 65 years; and * able to provide written informed consent for magnetic resonance imaging (MRI) and study participation. Exclusion Criteria for individuals diagnosed with BD: * a history of one or more diagnoses of the following DSM-5 categories: past or current moderate or severe substance dependence (303.x, 304.x, 305.x) with the exclusion of tobacco use disorder (305.1), neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x), schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x), neurocognitive disorders (290.x, 292.x, 294.x, 331.x), BD-I Single Manic (296.0x), BD-I Manic (296.4x), BD-I Mixed (296.6, 296.7, 296.8, 296.9), BD-II (296.89), or comorbid Borderline Personality Disorder (BPD) as assessed by Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD); * a current episode of illness with psychotic features (296.54); * a recent history of central nervous system (CNS) trauma or significant CNS trauma; * physical illness that might interfere with the participant's cognitive performance; * an autoimmune disorder or inflammatory diseases; * currently on anti-inflammatory drugs, cortisol or cortisol derivates; * cardiovascular impairment with life-threatening issues; * electroconvulsive therapy in the last 12 months; * current substance abuse (except caffeine and nicotine) as assessed by DSM-5 or positive urine drug screen; * IQ≤70 as assessed by the Mehrfachwahl-Wortschatztest" version B (MWT-B); * MRI contraindications (e.g. claustrophobia, metal, electric, magnetic or mechanically driven implants); or * other ethical considerations (e.g. pregnancy, lactation, participants not fluent in the language of the cognitive batteries and questionnaires). Inclusion Criteria for healthy volunteers: * absence of any axis I disorder according to DSM-5 and physical illness that might interfere with participant's cognitive performance; * age between 18 and 65 years according to clinical group; and * ability to give written informed consent for MRI and study participation. Exclusion Criteria for healthy volunteers: * first degree relatives with BD, schizophrenia, or known genetically-based mitochondriopathies; * a history of any axis I disorder, neurological, developmental disorders, CNS trauma, or comorbid BPD. * physical illness that might interfere with the participants' cognitive performance; * an autoimmune disorder or inflammatory diseases; * currently on anti-inflammatory drugs, cortisol or cortisol-derivates; * cardiovascular impairments with life-threatening issues; * current substance abuse; * IQ≤70; * MRI contraindications; or * other ethical considerations.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Medical University of Innsbruck

    Innsbruck, Tyrol, 6020, Austria

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Other studies related to the condition(s) this trial covers.