Depressive SymptomsNCT03626142
Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit
An observational study of Depressive Symptoms and Suicidal Ideation, run by Stanford University at 1 site in United States.
Trial summary
This study will monitor the symptoms of patients who have received an intervention on the psychiatric inpatient unit at Stanford hospital up to 6 months after they have received the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms, Suicidal Ideation
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2018to 4 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the psychiatric unit at Stanford University displaying depressive symptoms or suicidal ideation
Who may be able to join
- Received an intervention on the psychiatric inpatient unit at Stanford Hospital aimed at treating a major depressive episode or suicidal ideation
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
About this study
This study will monitor the symptoms of patients who have received an intervention on the psychiatric inpatient unit at Stanford hospital up to 6 months after they have received the intervention. Additionally, the acceptability and feasibility of interventions will be assessed using clinician and patient questionnaires.
Read the detailed description
Once patients have been discharged from hospital they will be contacted weekly for 4 weeks and then every 2 weeks until 6 months post-intervention in order to monitor their symptoms. Participants will be followed up until the end of the study (6 months after the intervention) or until they no longer meet responder criteria (MADRS score>50% of score before they received the intervention) During the follow-ups for the first 8 weeks, the following assessments will be conducted: Montgomery-Åsberg Depression Rating Scale (MADRS) Scale of suicidal ideation (SSI) Hamilton depression rating scale (HAMD-6) Young Mania Rating Scale (YMRS) Pittsburgh insomnia rating scale (PIRS-20) Quick inventory of depressive symptomatology (QIDS) Immediate Mood Scaler (IMS-12) Beck Depression Inventory (BDI-II) C-SSRS self-report short version
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) will be collected at one month post-intervention.
If the participant has a psychiatric diagnosis(/es) other than MDD, questionnaires measuring the symptoms associated with the participant's other psychiatric diagnosis/(es) will also be administered.
Follow-up assessments from 10-24 weeks will include:
MADRS SSI BDI-II C-SSRS self-report short version
If the participant has a psychiatric diagnosis other than MDD, questionnaires measuring the symptoms associated with the participant's other psychiatric diagnosis/(es) will also be administered.
The questionnaires that will be used to assess symptoms associated with primary psychiatric diagnoses are:
- Bipolar disorder: YMRS
- Schizoaffective disorder/ Schizophrenia/Schizophreniform disorder: positive and negative symptom scale (PANSS) and the Calgary Depression Scale for Schizophrenia (CDSS)
- Alcohol use disorder: Alcohol craving questionnaire self-report (ACQ-SR) and obsessive compulsive drinking scale (OCDS)
- Drug use disorders: Modified versions of the alcohol scales to make these relevant to the particular drug of abuse.
- Anorexia Nervosa: Yale-Brown-Cornell Eating Disorder Scale [YBC-EDS], Eating disorder examination questionnaire (EDE-Q)
- Bulimia Nervosa: Yale-Brown-Cornell Eating Disorder Scale [YBC-EDS], Eating disorder examination questionnaire (EDE-Q)
- Binge eating disorder: Young-Brown Obsessive Compulsive Scale Modified for Binge Eating [YBOCS-BE]
- OCD: Obsessive compulsive inventory (OCI) and Yale-Brown Obsessive Compulsive Scale (YBOCS)
- PTSD: Post-traumatic Stress Disorder Checklist-Civilian Version [PCL-C]
- Generalized anxiety disorder: Generalized Anxiety Disorder 7-item (GAD-7) scale
- Chronic pain: Numeric Rating Scale (NRS) for Chronic Pain
- Panic Disorder: Panic Disorder Severity Scale (PDSS)
- Somatoform Disorders: The Somatic Symptom Scale (SSS-8)
- Impulse Control disorders: Massachusetts General Hospital Hairpulling Scale (This questionnaire will be adapted depending on the urges the patient cannot control e.g. compulsive picking) BPD: The Borderline Evaluation of Severity Over Time (BEST)
At all time points, information regarding medication changes and other psychiatric treatments will be collected.
- Conditions
- Depressive Symptoms, Suicidal Ideation
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Left DLPFC aTBS stimulation | Patients who have received accelerated theta burst stimulation delivered to the left dorsolateral prefrontal cortex on the inpatient unit at Stanford | |
| ACC aTBS stimulation | Patients who have received accelerated theta burst stimulation delivered to the anterior cingulate cortex on the inpatient unit at Stanford | |
| ECT | Patients who have received ECT on the inpatient unit at Stanford |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
This is a ten-item clinician rated questionnaire in which the clinician rates each item from 0-6. Scores of 6 indicate more severe depressive symptoms. Total scores are between 0 and 60 with scores >35 indicating severe depression. Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of <10.
Measured: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Secondary outcomes (9)
Scale for Suicide Ideation (SSI)
Clinical assessment measuring suicidal thoughts \& behaviors
Measured: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Beck Depression Inventory II (BDI-II)
The Beck Depression Inventory (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.
Scores: 0-13= minimal depression, 14-19=mild depression, 20-28=moderate depression, 29-63=severe depression
Measured: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Columbia-Suicide Severity Rating Scale (C-SSRS)
Self-report questionnaire identifying the presence or absence of six suicidal thoughts or behaviors in the past month or since the last visit. Each 'yes' answer is scored as 1, meaning the maximum total score is 6.
The scale identifies specific behaviors which may be indicative of a person's intent to complete suicide. An person exhibiting even a single behavior identified by the scale was 8 to 10 times more likely to complete suicide.
Measured: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Young Mania Rating Scale (YMRS)
11-item multiple choice clinician-rated questionnaire. Each question is rated from 0 to 4 with 4
Measured: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Pittsburgh Insomnia Rating Scale (PIRS-20)
Self-report insomnia rating scale
Measured: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Hamilton Rating Scale for Depression Six Item (HAMD-6)
Response is defined as a 50% reduction or greater in HAMD-6 score compared to baseline. HAMD-6 is a 6-item clinical assessment measuring depressive symptoms (scores range from 0-24 with scores of 5 or more indicating clinical levels of depression). The number of weeks in which HAMD-6 scores are lower than 50% of baseline will be calculated to provide a measure of duration of response.
Measured: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Quick Inventory Depressive Symptomatology (QIDS)
Self-report measure of depressive symptoms
Measured: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Immediate Mood Scaler (IMS-12)
12-item self-report questionnaire used to measure current mood
Measured: weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Number of hospital re-admissions and service use
The number of times patients are re-admitted to hospital and used psychiatric services since the last assessment will be recorded
Measured: Bi-weekly up until 24 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start9 Jul 2018
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nolan Williams, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626142
- Sponsor's protocol ID
- 45301
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2018
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kelly MS, Oliveira-Maia AJ, Bernstein M, Stern AP, Press DZ, Pascual-Leone A, Boes AD. Initial Response to Transcranial Magnetic Stimulation Treatment for Depression Predicts Subsequent Response. J Neuropsychiatry Clin Neurosci. 2017 Spring;29(2):179-182. doi: 10.1176/appi.neuropsych.16100181. Epub 2016 Nov 30.
PubMed 27899052Haq AU, Sitzmann AF, Goldman ML, Maixner DF, Mickey BJ. Response of depression to electroconvulsive therapy: a meta-analysis of clinical predictors. J Clin Psychiatry. 2015 Oct;76(10):1374-84. doi: 10.4088/JCP.14r09528.
PubMed 26528644Berggren A, Gustafson L, Hoglund P, Johanson A. A long-term follow-up of clinical response and regional cerebral blood flow changes in depressed patients treated with ECT. J Affect Disord. 2014;167:235-43. doi: 10.1016/j.jad.2014.06.005. Epub 2014 Jun 12.
PubMed 24997226Murrough JW, Perez AM, Pillemer S, Stern J, Parides MK, aan het Rot M, Collins KA, Mathew SJ, Charney DS, Iosifescu DV. Rapid and longer-term antidepressant effects of repeated ketamine infusions in treatment-resistant major depression. Biol Psychiatry. 2013 Aug 15;74(4):250-6. doi: 10.1016/j.biopsych.2012.06.022. Epub 2012 Jul 27.
PubMed 22840761Dell'osso B, D'Urso N, Castellano F, Ciabatti M, Altamura AC. Long-term efficacy after acute augmentative repetitive transcranial magnetic stimulation in bipolar depression: a 1-year follow-up study. J ECT. 2011 Jun;27(2):141-4. doi: 10.1097/YCT.0b013e3181f66601.
PubMed 20966770
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit
- ClinicalTrials.gov ID
- NCT03626142
- Acronym / sponsor ID
- 45301
- Conditions
- Depressive Symptoms, Suicidal Ideation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will monitor the symptoms of patients who have received an intervention on the psychiatric inpatient unit at Stanford hospital up to 6 months after they have received the intervention. Additionally, the acceptability and feasibility of interventions will be assessed using clinician and patient questionnaires.
Detailed description
Once patients have been discharged from hospital they will be contacted weekly for 4 weeks and then every 2 weeks until 6 months post-intervention in order to monitor their symptoms. Participants will be followed up until the end of the study (6 months after the intervention) or until they no longer meet responder criteria (MADRS score>50% of score before they received the intervention) During the follow-ups for the first 8 weeks, the following assessments will be conducted: Montgomery-Åsberg Depression Rating Scale (MADRS) Scale of suicidal ideation (SSI) Hamilton depression rating scale (HAMD-6) Young Mania Rating Scale (YMRS) Pittsburgh insomnia rating scale (PIRS-20) Quick inventory of depressive symptomatology (QIDS) Immediate Mood Scaler (IMS-12) Beck Depression Inventory (BDI-II) C-SSRS self-report short version
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) will be collected at one month post-intervention.
If the participant has a psychiatric diagnosis(/es) other than MDD, questionnaires measuring the symptoms associated with the participant's other psychiatric diagnosis/(es) will also be administered.
Follow-up assessments from 10-24 weeks will include:
MADRS SSI BDI-II C-SSRS self-report short version
If the participant has a psychiatric diagnosis other than MDD, questionnaires measuring the symptoms associated with the participant's other psychiatric diagnosis/(es) will also be administered.
The questionnaires that will be used to assess symptoms associated with primary psychiatric diagnoses are:
- Bipolar disorder: YMRS
- Schizoaffective disorder/ Schizophrenia/Schizophreniform disorder: positive and negative symptom scale (PANSS) and the Calgary Depression Scale for Schizophrenia (CDSS)
- Alcohol use disorder: Alcohol craving questionnaire self-report (ACQ-SR) and obsessive compulsive drinking scale (OCDS)
- Drug use disorders: Modified versions of the alcohol scales to make these relevant to the particular drug of abuse.
- Anorexia Nervosa: Yale-Brown-Cornell Eating Disorder Scale [YBC-EDS], Eating disorder examination questionnaire (EDE-Q)
- Bulimia Nervosa: Yale-Brown-Cornell Eating Disorder Scale [YBC-EDS], Eating disorder examination questionnaire (EDE-Q)
- Binge eating disorder: Young-Brown Obsessive Compulsive Scale Modified for Binge Eating [YBOCS-BE]
- OCD: Obsessive compulsive inventory (OCI) and Yale-Brown Obsessive Compulsive Scale (YBOCS)
- PTSD: Post-traumatic Stress Disorder Checklist-Civilian Version [PCL-C]
- Generalized anxiety disorder: Generalized Anxiety Disorder 7-item (GAD-7) scale
- Chronic pain: Numeric Rating Scale (NRS) for Chronic Pain
- Panic Disorder: Panic Disorder Severity Scale (PDSS)
- Somatoform Disorders: The Somatic Symptom Scale (SSS-8)
- Impulse Control disorders: Massachusetts General Hospital Hairpulling Scale (This questionnaire will be adapted depending on the urges the patient cannot control e.g. compulsive picking) BPD: The Borderline Evaluation of Severity Over Time (BEST)
At all time points, information regarding medication changes and other psychiatric treatments will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Left DLPFC aTBS stimulation | – | –Patients who have received accelerated theta burst stimulation delivered to the left dorsolateral prefrontal cortex on the inpatient unit at Stanford |
| ACC aTBS stimulation | – | –Patients who have received accelerated theta burst stimulation delivered to the anterior cingulate cortex on the inpatient unit at Stanford |
| ECT | – | –Patients who have received ECT on the inpatient unit at Stanford |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the psychiatric unit at Stanford University displaying depressive symptoms or suicidal ideation
Key inclusion criteria (1 listed)
- Received an intervention on the psychiatric inpatient unit at Stanford Hospital aimed at treating a major depressive episode or suicidal ideation
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
This is a ten-item clinician rated questionnaire in which the clinician rates each item from 0-6. Scores of 6 indicate more severe depressive symptoms. Total scores are between 0 and 60 with scores >35 indicating severe depression. Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of <10.
9 secondary outcomes
Scale for Suicide Ideation (SSI)
Time frame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Beck Depression Inventory II (BDI-II)
Time frame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Young Mania Rating Scale (YMRS)
Time frame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Pittsburgh Insomnia Rating Scale (PIRS-20)
Time frame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Hamilton Rating Scale for Depression Six Item (HAMD-6)
Time frame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Quick Inventory Depressive Symptomatology (QIDS)
Time frame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Immediate Mood Scaler (IMS-12)
Time frame: weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Number of hospital re-admissions and service use
Time frame: Bi-weekly up until 24 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 27899052Kelly MS, Oliveira-Maia AJ, Bernstein M, Stern AP, Press DZ, Pascual-Leone A, Boes AD. Initial Response to Transcranial Magnetic Stimulation Treatment for Depression Predicts Subsequent Response. J Neuropsychiatry Clin Neurosci. 2017 Spring;29(2):179-182. doi: 10.1176/appi.neuropsych.16100181. Epub 2016 Nov 30.
- Background: PubMed 26528644Haq AU, Sitzmann AF, Goldman ML, Maixner DF, Mickey BJ. Response of depression to electroconvulsive therapy: a meta-analysis of clinical predictors. J Clin Psychiatry. 2015 Oct;76(10):1374-84. doi: 10.4088/JCP.14r09528.
- Background: PubMed 24997226Berggren A, Gustafson L, Hoglund P, Johanson A. A long-term follow-up of clinical response and regional cerebral blood flow changes in depressed patients treated with ECT. J Affect Disord. 2014;167:235-43. doi: 10.1016/j.jad.2014.06.005. Epub 2014 Jun 12.
- Background: PubMed 22840761Murrough JW, Perez AM, Pillemer S, Stern J, Parides MK, aan het Rot M, Collins KA, Mathew SJ, Charney DS, Iosifescu DV. Rapid and longer-term antidepressant effects of repeated ketamine infusions in treatment-resistant major depression. Biol Psychiatry. 2013 Aug 15;74(4):250-6. doi: 10.1016/j.biopsych.2012.06.022. Epub 2012 Jul 27.
- Background: PubMed 20966770Dell'osso B, D'Urso N, Castellano F, Ciabatti M, Altamura AC. Long-term efficacy after acute augmentative repetitive transcranial magnetic stimulation in bipolar depression: a 1-year follow-up study. J ECT. 2011 Jun;27(2):141-4. doi: 10.1097/YCT.0b013e3181f66601.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nolan Williams, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Symptoms and Suicidal Ideation, run by Stanford University at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention). 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 NCT03626142, which also lists 5 linked publications.
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 28 Oct 2026.