Effectiveness of psychostimulant and broader action antidepressant medications for patients with melancholic depressio

Phase 3

Recruiting

• Conditions: Melancholic Depression; Mental Health - Depression

• Registration Number: ACTRN12613000209796
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in depressive severity (via responder and remission rates) on the Quick Inventory of Depressive Symptomatology (QIDS). . <br><br><br>[QIDS: Baseline, weekly for 8 weeks after commencing trial medication, follow-up (at 8 weeks after commencing trial medication). <br>];Depressive symptom severity will be assessed by the Hamilton Depression Inventory (HAM-D).<br><br> A trial ‘responder’ is operationalized as an improvement of 50% or more and a ‘remitter’ by having a Hamilton score of less than seven at the trial’s conclusion.[HAMD: Baseline, fortnightly for 8 weeks after commencing trial medication, follow-up (at 8 weeks after commencing trial medication). <br>]