Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00178854
Other study ID # 030101
Secondary ID RIS-BIP-404VUMC3
Status Withdrawn
Phase Phase 4
First received September 12, 2005
Last updated March 30, 2017
Start date May 2004
Est. completion date March 2006

Study information

Verified date March 2017
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study of the chemistry of depression in people who are taking an antidepressant but it is not working well. The changes in brain chemicals that occur when an SSRI type antidepressant is supplemented with risperidone (Risperdal®) will be studied. Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. The study has potential to help understand and treat depression.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Treatment-resistant unipolar depression (previous diagnosis of MDD by SCID-P or DSM-IV) as defined by inadequate or waning response to adequate SRI treatment for at least 4 weeks

- HRSD (17-item) score greater than or equal to 15 while taking an SRI with no past suicide attempts for one year and no current ideation, intent, or plan. Repeat HRSD scores should remain greater than or equal to 15 for two consecutive weeks after initial screening.

Exclusion Criteria:

- Adverse extrapyramidal or other response to dopamine antagonist effects in the past.

- Any adverse response to risperidone in the past.

- Residence beyond 30 miles from Vanderbilt University.

- Inability to comply with study requirements.

- Psychotic hallucinations

- Past diagnosis of Bipolar, Dissociative, or Psychotic Disorders.

- Substance or alcohol abuse, other psychotropic, or any investigational or herbal preparation within 3 months or Substance dependency within 6 months prior to initial screening (by SCID-P).

- History of impulsive suicidal gestures or attempts within 2 years (must have no suicidal ideation, intent or plan for a period of one year).

- Primary diagnosis of Cluster B or C personality disorder, or significant comorbidity due to Borderline, Antisocial, Schizoid, or Schizotypal Personality Disorder (by SCID-II).

- Seasonal affective syndromes, including Seasonal Affective Disorder (because the duration of the study is long enough to expect "spontaneous" [natural] remissions.)

- Chronic (daily) benzodiazepine use in the past month or any use 1 week prior to sampling.

- Regular analgesic use. No antipyretic medication is allowed in the pre- through post-sampling period, leaving difficulty with pain management for pain-prone patients.

- Medication use deemed by the investigator unacceptable for study protocol.

- Pregnancy or inability to cooperate with effective contraceptive method (double barrier).

- Physical condition or significant medical history of any illness that presents risk with lumbar catheterization.

- Lactation.

- Blood donation within 90 days prior to or planned 90 days following the study.

- Severe migraine history.

- Daily tobacco use (absolute abstinence is required during the entire study.)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Risperidone


Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center Janssen, LP

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Recruiting NCT04124341 - PCS in Severe Treatment Resistant Depression N/A
Recruiting NCT03887715 - A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression N/A
Completed NCT04727229 - Stellate Ganglion Block for Major Depressive Disorder. Phase 4
Completed NCT04634669 - Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE) Phase 2
Withdrawn NCT03175887 - Investigational TMS Treatment for Depression N/A
Completed NCT03134066 - Neurocognitive Features of Patients With Treatment-Resistant Depression
Active, not recruiting NCT01984710 - Deep Brain Stimulation for Treatment Resistant Depression With the Medtronic Activa PC+S N/A
Completed NCT01935115 - Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy Phase 4
Terminated NCT01687478 - A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression Phase 3
Completed NCT00531726 - Berlin Deep Brain Stimulation Depression Study N/A
Recruiting NCT04041479 - Biomarker-guided rTMS for Treatment Resistant Depression Phase 3
Recruiting NCT05870540 - BPL-003 Efficacy and Safety in Treatment Resistant Depression Phase 2
Recruiting NCT04959253 - Psilocybin in Depression Resistant to Standard Treatments Phase 2
Completed NCT04856124 - Intranasal Esketamine to Maintain the Antidepressant Response to IV Racemic Ketamine
Recruiting NCT03272698 - ECT With Ketamine Anesthesia vs High Intensity Ketamine With ECT Rescue for Treatment-Resistant Depression Phase 4
Active, not recruiting NCT04451135 - CET- REM (Correlating ECT Response to EEG Markers) N/A
Recruiting NCT05680220 - 40 Hz Light Neurostimulation for Patients With Depression (FELIX) N/A
Completed NCT03288675 - Stepped Care aiTBS 2 Depression Study (Ghent) N/A
Recruiting NCT06138691 - KET-RO Plus RO DBT for Treatment Resistant Depression Phase 1
Terminated NCT02675556 - Allogeneic Human Mesenchymal Stem Cells (hMSCs) Infusion in Patients With Treatment Resistant Depression Phase 1

External Links