Self Injurious Behavior / Behavioral Symptoms / Suicide · Observational Study

Natural History of Depression, Bipolar Disorder and Suicide Risk

ClinicalTrials.gov · August 14, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry record for an ongoing observational study sponsored by NIMH to characterize the natural history of depression, bipolar disorder, and suicide risk during routine clinical treatment. No results are reported in this registry entry; the study is currently recruiting participants and has not yet yielded outcome data.

What was studied

Observational. Behavioral Symptoms, Suicide, Self-Injurious Behavior, Sensory System Agents, Analgesics, Peripheral Nervous System Agents, Physiological Effects of Drugs, Ane…; age from 18 Years; to 120 Years. Intervention: Bipolar Disorder; Major Depressive Disorder; Suicide Risk. n = 500. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record describing an ongoing observational study with no results posted; it documents planned enrollment and outcome measures only.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Score on Montgomery Asberg Depression Rating Scale (assessed at Weekly)

DesignObservational

PopulationBehavioral Symptoms, Suicide, Self-Injurious Behavior, Sensory System Agents, Analgesics, Peripheral Nervous System Agents, Physiological Effects of Drugs, Ane…; age from 18 Years; to 120 Years

Sample size500

InterventionBipolar Disorder; Major Depressive Disorder; Suicide Risk

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment500

Primary outcome measureScore on Montgomery Asberg Depression Rating Scale, Weekly

Study durationup to 12 weeks

Caveats

This is a registry record only; no results are reported and the study is still recruiting.
Observational design without control arm limits causal inference.
Outcome data, effect sizes, and clinical findings are not yet available.
Optional assessments (psychological testing, blood draws, sleep tests, imaging) may have incomplete participation.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational study without control group or randomization.

Directness

moderate

Enrolls patients with mood disorders and suicide risk undergoing clinical care.

Consistency

insufficient

Registry record; no results reported for comparison with other evidence.

Risk of bias

insufficient

Study is ongoing; no methods detail provided to assess bias.

Sample adequacy

limited

Estimated 500 participants; observational design limits statistical power.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06462196). This is a study registration, not published results. Lead sponsor: National Institute of Mental Health (NIMH). Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 500 participants (ESTIMATED). Conditions: Behavioral Symptoms, Suicide, Self-Injurious Behavior, Sensory System Agents, Analgesics, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anesthetics, Dissociative, Anesthetics, General, Anesthetics, Central Nervous System Depressants, Excitatory Amino Acid Antagonists, Excitatory Amino Acid Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Ketamine, Depression, Unipolar, Depressive Symptoms, Treatment Resistant Depression, Major Depressive Disorder, Depression, Bipolar. Primary outcome measures: Score on Montgomery Asberg Depression Rating Scale , Weekly. Brief summary: Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT06462196Self Injurious BehaviorBehavioral SymptomsSuicideNational Institute of Mental Health (NIMH)