None listed
Conditions
Brief summary
The primary aim of the study to evaluate the effectiveness of MPD as a monotherapy and adjunctive antidepressant treatment in patients with melancholic depression who have failed orthodox antidepressant options. Key Hypotheses: 1. Those receiving MPD and an antidepressant will show superior responder and remission rates compared to those receiving an antidepressant only 2. Those receiving MPD monotherapy will show comparable remission and responder rates to those in Group 2 (a non-inferiority hypothesis). 3. Those receiving MPD will improve more rapidly than those on antidepressants only 4. Substantive side-effects and drop-out rates will be lowest for patients on MPD only.
Interventions
The trial involves three treatment groups:
1. Methylphenidate (MPD) monotherapy (Group 1)
2. Antidepressant monotherapy (group 2)
3. MPD and antidepressant combination Group 3)
Administration of medication will be as follows for the three treatment groups:
Group 1: : MPD will be progressively titrated up from 10 mg (taken daily) and with the dose increase ceased if the subject reports (i) a full response or significant side-effects, or (ii) no improvement beyond that of previous dose increase,
The trial involves three treatment groups: 1. Methylphenidate (MPD) monotherapy (Group 1) 2. Antidepressant monotherapy (group 2) 3. MPD and antidepressant combination Group 3) Administration of medication will be as follows for the three treatment groups: Group 1: : MPD will be progressively titrated up from 10 mg (taken daily) and with the dose increase ceased if the subject reports (i) a full response or significant side-effects, or (ii) no improvement beyond that of previous dose increase, or (iii) mood worsens on dose increase. Maximum dose of 30 mg/day. The managing clinician will assess clinical progress, pulse rate and blood pressure on a fortnightly basis. Group 2: Administration of a dual or broad-action antidepressant, with decision dictated by previous failed antidepressant drug classes. Subjects who have only trialed an selective serotonin reuptake inhibitor (SSRI) will be prescribed a dual action antidepressant (desvenlafaxine) while patients that have previously trialed a dual-action drug will be prescribed a tricyclic antidepressant (dothiepin). These medications will be administered and titrated in line with current clinical procedures and patients will be clinically reviewed fortnightly. Group 3: As above, for MPD. Antidepressant will be selected in line with previous antidepressants trialed by patient and titrated in line with standard clinician practice. MPD will be administered in tablet form (10mg tablets; Trade name: Ritalin) with approval for prescription sought from the Pharmaceutical Branch of NSW Health per standard clinical procedures. The antidepressant dose will be administered in line with standard clinical procedure and on a case by case basis with (as for MPD) the dose increase ceased if the subject reports (i) a full response or significant side-effects, or (ii) no improvement beyond that of previous dose increase, or (iii) mood worsens on dose increase. Maximum dose administered in line with standard clinical guidelines.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Outcome results
None listed