Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Depressive Episode, Posttraumatic Stress Disorder, Traumatic Brain Injury

In brief

The purpose of this study is to determine whether transcranial magnetic stimulation (TMS) is effective in the treatment of suicidal thinking in individuals with a depressive episode and either posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (TBI), or both conditions.

Key facts

Study ID

NCT01212848

Run by

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

People needed

42

Starts

2010-10-01

Expected to finish

2013-10-01

Last updated by the study team

2013-04-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Veteran inpatients aged 18-70 years inclusive, with a depressive episode.
• Must also have either or both
• a diagnosis of PTSD as defined by DSM-IV supported by the SCID, or
• a diagnosis of mild TBI, either complicated (i.e., with imaging abnormalities) or uncomplicated, as defined by INTRuST criteria. The American Congress of Rehabilitation Medicine (ACRM) definition of mild TBI will be utilized for this study (Kay et al., 1993). That definition will be operationalized using the INTRuST Screening Instrument.
• Admitted because of suicidal ideation.
• SSI score > 12.
• HRSD question #3 > 3.
• Female subjects of childbearing potential must have a negative urine pregnancy test.
• Comorbid (non-principal) diagnoses of psychiatric disorders not explicitly listed in the following Exclusion Criteria section are generally permitted (with final eligibility determination by Site Principal Investigator clinical assessment).
• Subjects must be able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
• After full explanation of the study, subjects must demonstrate their willingness to participate by signing the informed consent form.

You may not qualify if…

• Subjects who have clinically unstable medical disease (cardiovascular, renal, gastrointestinal, pulmonary, metabolic, endocrine, other); CNS disease deemed progressive; moderate or severe traumatic brain injury (TBI). Patients with mild TBI, however, will not be excluded from study participation. The ACRM definition of mild TBI will be utilized for this study (Kay et al., 1993). That definition will be operationalized using the INTRuST TBI Screening Instrument.
• Females who are pregnant or currently breast feeding.
• Current or history of schizophrenia or other psychotic disorder (except psychosis NOS when the presence of sensory hallucinations are clearly related to the subject's trauma), bipolar Type I disorder, or dementia (vascular, Alzheimer's disease, other types). Patients with bipolar Type II disorder will not be excluded.
• Subjects who repeatedly abused or were dependent upon drugs (excluding nicotine and caffeine) within 6 days of study entry will be excluded, (with the exception of alcohol abuse which, at the discretion of the primary site investigator, may be permitted*).
• Subjects actively participating (or planning to enroll) in an evidence-based exposure/cognitive treatment for PTSD during the trial, or who have been enrolled in one during the past 6 weeks; participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and remain stable throughout participation.
• Subjects currently taking medications that have short half-lives, lower the seizure threshold, and do not have evidence of antidepressant efficacy. These include high dose theophylline, or stimulants such as methylphenidate. Patients taking buproprion have to be on a stable dose and take less than or equal to 300 mg/day. Stable means the same dose for 5 half-lives.
• Subjects with metal in their head (other than dental implants), implanted devices in their head (shunts, cochlear implants).
• Subjects with a history of seizures or a seizure disorder.
• Subjects with borderline personality disorder or who have clear evidence of secondary gain as a reason for admission.

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Ralph H. Johnson VA Medical Center — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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