Randomized controlled trial of methylphenidate (either as a monotherapy or an adjunct treatment) compared to an antidepressant group (dual action or tricyclic antidepressants) for patients with treatment-resistant melancholic depression to see if effective in improvement in depression ratings and remission over an 8-week period.

niversity of New South Wales0 个研究点目标入组 225 人开始时间: 2013年2月21日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Inclusion Criteria:
•1.Aged 18-65 years
•2.Diagnosis of a unipolar melancholic depression according to a Black Dog Institute psychiatrist and DSM IV-TR criteria (measured by MINI)
•3.Currently depressed with depressive onset present for at least 4 weeks
•4.Score on HAM-D equal to or greater than 14 and score on QIDS equal to or greater than 11 (i.e. moderately to severely depressed)
•5.Failed two or more SSRI or dual action antidepressants (but never trialed a TCA or monoamine oxidase inhibitor (MAOI))
•6.Willing to accept randomized assignment to one of the three treatment options.
•7.Prepared to commit to fortnightly visits to the BDI and participate in weekly phone calls with the researcher who will complete the QIDS and monitor side effects.
•8.Able to provide written informed consent.

•Exclusion Criteria
•1.Under 18 years of age, or over 65.
•2.Poor written and/or spoken English.
•3.Pregnant or breastfeeding
•4.Medical condition which contraindicates any trial treatment groups (e.g. epilepsy, cardiovascular condition, resting pulse rate above 80, blood pressure above 140/100).
•5.Currently psychotic or acutely suicidal
•6.Current drug or alcohol problems
•7.Has previously trialed a psychostimulant or was a previous ‘user’ of psychostimulant.

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