drugset / Trial / NCT01179568
A Study of Medication With or Without Psychotherapy for Complicated Grief
Phase 2
Completed
395 enrolled
New York State Psychiatric Institute
American Foundation for Suicide Prevention · collabNational Institute of Mental Health (NIMH) · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
The major goal of this 4-site, double blind, placebo-controlled intervention trial is to assess the efficacy of medication (Citalopram) alone or with psychotherapy (Complicated Grief Therapy) to treat the symptoms of complicated grief.
Timeline
- Start
- 2010-03
- Primary completion
- 2015-02
- Completion
- 2015-07
Publications
- Background Simon NM, Thompson EH, Pollack MH, Shear MK. Complicated grief: a case series using escitalopram. Am J Psychiatry. 2007 Nov;164(11):1760-1. doi: 10.1176/appi.ajp.2007.07050800. No abstract available.
- Background Shear K, Frank E, Houck PR, Reynolds CF 3rd. Treatment of complicated grief: a randomized controlled trial. JAMA. 2005 Jun 1;293(21):2601-8. doi: 10.1001/jama.293.21.2601.
- Background Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967 Aug;20(8):637-48. doi: 10.1016/0021-9681(67)90041-0. No abstract available.
- Background Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003 Sep 24;290(12):1624-32. doi: 10.1001/jama.290.12.1624.
- Background Jacobs SC, Nelson JC, Zisook S. Treating depressions of bereavement with antidepressants. A pilot study. Psychiatr Clin North Am. 1987 Sep;10(3):501-10.
- Background Shear MK. Clinical practice. Complicated grief. N Engl J Med. 2015 Jan 8;372(2):153-60. doi: 10.1056/NEJMcp1315618. No abstract available.
- Calderon A, Irwin M, Simon NM, Shear MK, Mauro C, Zisook S, Reynolds CF 3rd, Malgaroli M. Depression is Associated with Treatment Response Trajectories in Adults with Prolonged Grief Disorder: A Machine Learning Analysis. medRxiv [Preprint]. 2024 Dec 12:2024.12.11.24318861. doi: 10.1101/2024.12.11.24318861.
- Na PJ, Adhikari S, Szuhany KL, Chen AZ, Suzuki RR, Malgaroli M, Robinaugh DJ, Bui E, Mauro C, Skritskaya NA, Lebowitz BD, Zisook S, Reynolds CF 3rd, Shear MK, Simon NM. Posttraumatic Distress Symptoms and Their Response to Treatment in Adults With Prolonged Grief Disorder. J Clin Psychiatry. 2021 Apr 20;82(3):20m13576. doi: 10.4088/JCP.20m13576.
- Zisook S, Shear MK, Reynolds CF, Simon NM, Mauro C, Skritskaya NA, Lebowitz B, Wang Y, Tal I, Glorioso D, Wetherell JL, Iglewicz A, Robinaugh D, Qiu X. Treatment of Complicated Grief in Survivors of Suicide Loss: A HEAL Report. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11592. doi: 10.4088/JCP.17m11592.
- Shear MK, Reynolds CF 3rd, Simon NM, Zisook S, Wang Y, Mauro C, Duan N, Lebowitz B, Skritskaya N. Optimizing Treatment of Complicated Grief: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):685-94. doi: 10.1001/jamapsychiatry.2016.0892.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Citalopram | Small molecule | 40 mg | — |
Indications
No indication recorded.