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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 17, 2000 | ||||||||
| Last Updated Date | June 23, 2005 | ||||||||
| Start Date ICMJE | |||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00000390 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Antidepressant Treatment of AIDS Related Depression. | ||||||||
| Official Title ICMJE | |||||||||
| Brief Summary | To test the effectiveness treating AIDS related depression with imipramine hydrochloride. Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status. This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride. |
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| Detailed Description | To test the effectiveness treating AIDS related depression with imipramine hydrochloride. Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status. This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Placebo Control | ||||||||
| Condition ICMJE | Depression | ||||||||
| Intervention ICMJE | Drug: Imipramine hydrochloride | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00000390 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 87-DEP | ||||||||
| Study Sponsor ICMJE | GEIGY Pharmaceuticals | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | April 2000 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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