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DepressionSAMSNCT00532103

Assessing Treatment Emergent Suicidal Ideation in Patients With Major Depression

An observational study of Depression, run by National Institute of Mental Health (NIMH) at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will develop a new methodology to evaluate any treatment-emergent suicidal ideation that might occur when an antidepressant treatment has been started and/or during times when doses are increased in patients with major depressive disorder. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Depression
How many people
300 participants
Where
15 sitesUnited States
Study dates
Jul 2007to Feb 2008
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Fifteen primary care and specialty care clinics across the country.

Who may be able to join

  • ONLY PATIENTS BEING TREATED AT THE PARTICIPATING CLINICS ARE ELIGIBLE FOR THIS STUDY
  • Patients must be enrolled at the primary or specialty care site, and be planning to continue living in the area of that clinic throughout the study
  • Patients must be 18-75 years old
  • Patients must meet clinical criteria for MDD, based on clinical interview and DSM IV MDD checklist
  • Screening HAM-D17 score greater than or equal to 14
  • Patients must give written informed consent
  • Patients with and without current suicidal ideation may be included in the study
  • Patients must not have taken antidepressant medication for at least 2 weeks prior to screen (or 4 weeks in the case of fluoxetine).

Who cannot join

  • Current substance abuse or dependence
  • Two past SSRI treatment failures within the current episode, or last 2 years if chronic.
  • Patients with a current Axis I diagnosis of Bipolar disorder or Schizophrenia
  • Patients with a current Primary Axis I diagnosis of Obsessive-Compulsive disorder, Anorexia Nervosa or Bulimia.
  • Women who are sexually active and who are not using adequate contraception, or who are pregnant, trying to become pregnant, or breast feeding.
  • Patients with general medical conditions that contraindicate antidepressant medications
Show all 9Show fewer
  • Patients whose clinical status requires inpatient treatment at the time of baseline interview.
  • Patients who cannot read and understand English since all research instruments are not yet translated and validated in Spanish or other languages.
  • Some reports of SSRI-induced akathisia-like states have found them to be more highly correlated with either concurrent or previous treatment with a neuroleptic, even in patients with no history of movement disorders therefore, patients who have taken an anti-psychotic medication within 4 months of the screening visit will be excluded from the study.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • General Psychiatric Ambulatory Clinic

    Ann Arbor, Michigan, 48105

  • UNC Chapel Hill Adult Diagnostic & Treatment Clinic

    Chapel Hill, North Carolina, 27599-7160

  • Northwestern Psychiatric Outpatient Treatment Care Center

    Chicago, Illinois, 60611

  • UT Southwestern Family Medicine Clinic

    Dallas, Texas, 75390

  • Harbor UCLA Family Health Care Center

    Harbor City, California, 90710

  • UCLA Internal Medicine Clinic

    Los Angeles, California, 90024

  • Vine Hill Community Clinic

    Nashville, Tennessee, 37212

  • Irving Goldman Primary Care at North Shore Hospital

    New York, New York, 11040

  • Bellefield Clinic of WPIC

    Pittsburgh, Pennsylvania, 15213

  • VCU Outpatient Psychiatry Clinic

    Richmond, Virginia, 23298

  • MGH/Northshore Medical Center (Salem Psychiatric Facility)

    Salem, Massachusetts, 01970

  • Veterans Affairs Medical Center/FIRM Primary Care Clinic

    San Diego, California, 92161

  • Laureate Psychiatric Clinic and Hospital

    Tulsa, Oklahoma, 74135

  • Tuscalossa VA Mental Health Clinic

    Tuscaloosa, Alabama, 35404

  • Clinical Research Institute

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: Suicide Assessment Methodology Study (SAMS)

This study will develop a new methodology to evaluate any treatment-emergent suicidal ideation that might occur when an antidepressant treatment has been started and/or during times when doses are increased in patients with major depressive disorder.

Read the detailed description

This is a pilot study to begin to develop a measurement procedure to help guide the clinical management of suicide risk in people beginning a type of antidepressant medication called a selective serotonin reuptake inhibitor (SSRI). The goals of the study are: 1) to identify the best method and assessment measures to evaluate the severity of suicidal ideation, 2) to determine the appropriate frequency and duration of assessment required to adequately evaluate this suicidal ideation, 3) to evaluate the presence of symptoms that are associated with suicidal ideation (such as anxiety, panic attacks, difficulty in sleeping) and 4) to identify the most critical time periods during which suicidal ideation appears or worsens (such as how long after initiation of treatment or dosage increase).

In all, 300 adult participants with major depressive disorder (MDD), between the ages of 18 and 75, may be enrolled at primary and psychiatric care sites across the US. All patients will be treated with an SSRI for eight weeks. The choice of SSRI used in treatment will be chosen by the study physician at each site. For this study, physicians will choose from the following six SSRIs: citalopram, escitalopram, sertraline, paroxetine, paroxetine-CR, and fluoxetine.

Patients beginning an SSRI for MDD in "real world" psychiatric and primary care settings, will have clinic visits and receive evaluations of their symptoms of depression, side effects, suicidal thinking and symptoms that are thought to be associated with suicidal risk, every other week for eight weeks. They will be evaluated by phone for symptoms and side effects each week they do not come to the clinic. They will also receive phone calls three times a week for the first two weeks of the study, after beginning the antidepressant, and after a dose increase to evaluate suicide risk.

Conditions
Depression
Keywords
Suicidal Ideation, Major Depressive Disorder, Suicide Risk, Antidepressant Medication
Medical subject headings
Depression, Suicidal Ideation, Depressive Disorder, Major

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

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
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00532103
Sponsor's protocol ID
N01 MH90003-01
Other IDs
DSIR AT, N01MH90003
Acronym
SAMS
Status last verified
Sep 2008
First submitted
18 Sep 2007
Last updated
22 Sep 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Jha MK, Minhajuddin A, South C, Rush AJ, Trivedi MH. Irritability and Its Clinical Utility in Major Depressive Disorder: Prediction of Individual-Level Acute-Phase Outcomes Using Early Changes in Irritability and Depression Severity. Am J Psychiatry. 2019 May 1;176(5):358-366. doi: 10.1176/appi.ajp.2018.18030355. Epub 2019 Mar 29.

    PubMed 30922100

  • Gollan JK, Fava M, Kurian B, Wisniewski SR, Rush AJ, Daly E, Miyahara S, Trivedi MH. What are the clinical implications of new onset or worsening anxiety during the first two weeks of SSRI treatment for depression? Depress Anxiety. 2012 Feb;29(2):94-101. doi: 10.1002/da.20917. Epub 2011 Dec 6.

    PubMed 22147631

  • Trivedi MH, Wisniewski SR, Morris DW, Fava M, Kurian BT, Gollan JK, Nierenberg AA, Warden D, Gaynes BN, Luther JF, Rush AJ. Concise Associated Symptoms Tracking scale: a brief self-report and clinician rating of symptoms associated with suicidality. J Clin Psychiatry. 2011 Jun;72(6):765-74. doi: 10.4088/JCP.11m06840.

    PubMed 21733477

  • Trivedi MH, Wisniewski SR, Morris DW, Fava M, Gollan JK, Warden D, Nierenberg AA, Gaynes BN, Husain MM, Luther JF, Zisook S, Rush AJ. Concise Health Risk Tracking scale: a brief self-report and clinician rating of suicidal risk. J Clin Psychiatry. 2011 Jun;72(6):757-64. doi: 10.4088/JCP.11m06837.

    PubMed 21733476

  • Warden D, Trivedi MH, Wisniewski SR, Kurian B, Zisook S, Kornstein SG, Friedman ES, Miyahara S, Leuchter AF, Fava M, Rush AJ. Early adverse events and attrition in selective serotonin reuptake inhibitor treatment: a suicide assessment methodology study report. J Clin Psychopharmacol. 2010 Jun;30(3):259-66. doi: 10.1097/JCP.0b013e3181dbfd04.

    PubMed 20473060

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, run by National Institute of Mental Health (NIMH) at 15 sites 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 8 inclusion and 9 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 22 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00532103, 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 22 Sep 2008.

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